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Food and Drug Administration / Gloves / Medical technology / Food law / Protective gear / Medical device / Federal Food /  Drug /  and Cosmetic Act / Medical glove / Center for Devices and Radiological Health / Medicine / Health / Technology


ASSURGUARD SDN. BHD. (Company No[removed]H) FEB[removed]FDA 510(k), Premnarket Notification : 510(k) Summary of Safety and Effectiveness Information Date: 01 December 2012
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Document Date: 2013-03-08 15:19:08


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File Size: 187,11 KB

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City

Selangor Darul Ehsan / /

Company

K123757 Trade / 5 ASSURGUARD SDN. / ASSURGUARD SDN. / /

Country

Malaysia / /

Event

FDA Phase / /

Facility

General Hospital / Drug Administration Document Control Center / /

IndustryTerm

announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /

Organization

Public Health Service Food and Drug Administration Document Control Center / CA V / M.B.A. Director Division of Anesthesiology / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / office of Surveillance / FDA / General Hospital / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / Division of Postrnarket Surveillance / /

Person

Lim Hui Guan / Anthony D. Watson / /

/

Position

Director Assurguard Sdn. / Managing Director / /

Product

Federal Food / /

ProgrammingLanguage

Latex / /

ProvinceOrState

Maryland / /

Technology

radiation / /

URL

assurguard~gmail.com / http /

SocialTag