Subject Device

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March 19, 2021 Elijah Wreh Regulatory Affairs Manager One

15 Pages
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march 19, 2021 invacare corporation elijah wreh regulatory affairs manager one invacare way elyria, ohio 44035 re: k202379 trade/device name: invacare aviva storm rx power chair regulation number: 21 cfr 890.3860 regulation name: powered wheelchair regulatory class: class ii product code: iti dated: february 10, 2021 received: february 16, 2021

November 6, 2020 Eran Levit Official Correspondent Regulation

8 Pages
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gtimd llc eran levit official correspondent 6 columbia drive amherst, nh 03031 november 6, 2020 re: k202427 trade/device name: aqueduct 100 plus cervical dilation balloon catheter regulation number: 21 cfr § 884.4260 regulation name: hygroscopic laminaria cervical dilator regulatory class: ii product code: pon dated: september 30, 2020

January 18, 2019 James W. Monroe Director, Regulatory Affairs

7 Pages
763 KB

pentax of america, inc. james w. monroe director, regulatory affairs 3 paragon drive montvale, nj 07645-1782 january 18, 2019 re: k181084 trade/device name: pentax video colonoscopes (ec family) regulation number: 21 cfr§ 876.1500 regulation name: endoscope and accessories regulatory class: ii product code: fdf dated: december 18, 2018

Regulated-level device management for BlackBerry 10

3 Pages
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blackberry service 10 enterprise regulated-level device management for blackberry 10 regulated-level enterprise mobility management (emm) control options are available for blackberry® 10 smartphones to enable compliance for secure, government and regulated environments. where a high degree of granular control over device features is required and for enterprises

Full device management for iOS, Android and BlackBerry

4 Pages
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blackberry service 10 enterprise full device management for ios, android and blackberry blackberry enterprise service 10 is a unified multi-os device, application and content management platform with integrated security and connectivity enabling you to effectively manage complex fleets of mobile devices. bes10 makes it simple to manage

The EU Medical Device Regulation and the U.S. Medical Device

2 Pages
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u.s. international trade commission (usitc) executive briefings on trade, september 2018 the eu medical device regulation and the u.s. medical device industry brian daigle, office of industries ([email protected], 202-205-3458) mihir torsekar, office of industries ([email protected], 202-205-3350) by may 26, 2020, all components of the european union’s medical device

Subject headings context and scope notes

2 Pages
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6 – subject headings – context and scope notes when you do a psycinfo search with the “map term to subject heading” ticked/selected, you get a list of subject headings which match the term that you’ve used. you may get a longer or a shorter list, depending on how good

The Subject Complement

3 Pages
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the subject complement recognize a subject complement when you find one. a subject complement is the adjective, noun, or pronoun that follows a linking verb. the following verbs are true linking verbs: any form of be (am, is, are, was, were, has been, are being, might have been, etc.), become,


4 Pages
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unit 4 – agreement of subject and verb subject and verb agreement every verb must agree with its subject in person and number. therefore, a singular subject requires a singular subject requires a singular form of the verb. the following indefinite pronouns are always singular. each no

H 200 Preparation of Subject Heading Proposals

22 Pages
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preparation of subject heading proposals h 200 contents background .2 general requirements for subject heading proposals: 1. accessing the system 2 2. accessing templates for new headings . 3-4 3. general information about entering data in the templates 4-5 4. “generated by” . 6-7 5. field 008/06 (geographic

Active Advantage Alliance Plan Schedule of Benefits - MCHS

21 Pages
1 MB

marshfield clinic health systems group numbers:100649 effective date: april 1, 2022 benefit year: april 1 – march 31 non-grandfathered plan active advantage alliance plan schedule of benefits security administrative services, llc certifies that you and any covered dependents have coverage as described in your summary plan document and


24 Pages
99.1 KB

subject specialism: consultation document photo redacted due to third party rights or other legal issues photo redacted due to third party rights or other legal issues march 2003 introduction teacher professionalism and the role of subject specialism 1. our very best teachers are those who have a real passion

Loredana Guseila Director of Regulatory and Clinical Affairs

10 Pages
266.3 KB

march 26, 2020 novus scientific ab ℅ loredana guseila director of regulatory and clinical affairs cygnus regulatory, llc 5555 e palo verde drive paradise valley, arizona 85253 re: k191749 trade/device name: tigr matrix surgical mesh, tigr surgical mesh regulation number: 21 cfr 878.3300 regulation name: surgical mesh regulatory class: class

September 27, 2018 Biosphere Medical, S.A. Alix Fonlladosa

6 Pages
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september 27, 2018 biosphere medical, s.a. alix fonlladosa regulatory affairs manager parc des nations – paris nord 2, 383 rue de la belle etoile roissy en france, 95700 fr re: k181021 trade/device name: embocube embolization gelatin regulation number: 21 cfr 870.3300 regulation name: vascular embolization device regulatory class: class ii

EWOO SOFT Co., Ltd. March 13, 2020 Ms. Priscilla Chung

7 Pages
499 KB

ewoo soft co., ltd. ℅ ms. priscilla chung regulatory affairs consultant lk consulting group usa, inc. 1150 roosevelt ste 200 irvine ca 92620 march 13, 2020 re: k192888 trade/device name: ezortho regulation number: 21 cfr 892.2050 regulation name: picture archiving and communications system regulatory class: class ii product

Becton Dickinson and Company Meriam Youssef 1 Becton Drive

7 Pages
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october 21, 2019 becton dickinson and company meriam youssef senior manager regulatory affairs 1 becton drive franklin lakes, new jersey 07417 re: k190054 trade/device name: bd insulin syringe regulation number: 21 cfr 880.5860 regulation name: piston syringe regulatory class: class ii product code: fmf dated: september 19, 2019 received: september

November 25, 2020

11 Pages
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november 25, 2020 guangzhou xinbo electronic co., ltd. ℅ cassie lee manager guangzhou glomed biological technology co., ltd. 2231, building 1, rui feng center, kaichuang road, huangpu district guangzhou, 510700 china re: k200402 trade/device name: dr-ho's electro therapy conductive gel regulation number: 21 cfr 882.175 regulation name: electroconductive media regulatory

f9 - Food and Drug Administration

5 Pages
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mar 2 3 2004 510o(k) summary newmedical newmedical technology, inc n.14 w.23833 stone ridge dr. wau~keshawi 53188 usa 262- 523 0521 main 262- 513 0799 fax 262-39 1 7899 mobile suite giqo 9%be f9 dat~e of submission: submitted by: december 10, 2003

SonarMed, Inc. Laura Lyons VP Compliance & Respiratory Care

9 Pages
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may 15, 2020 sonarmed, inc. laura lyons vp compliance & respiratory care 12220 n. meridian st., ste. 150 carmel, indiana 46032 re: k193058 trade/device name: sonarmed airwave airway monitoring system regulation number: 21 cfr 868.5730 regulation name: tracheal tube regulatory class: class ii product code: oqu dated: april 10, 2020

September 20, 2019 Julie Perkins Sr. Director, Quality

11 Pages
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september 20, 2019 insulet corporation julie perkins sr. director, quality assurance and regulatory affairs 100 nagog park acton, ma 01720 re: k191679 trade/device name: omnipod dash insulin management system with interoperable technology regulation number: 21 cfr 880.5730 regulation name: alternate controller enabled infusion pump regulatory class: class ii product code: