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Food and Drug Administration / Medical equipment / Heat transfer / Physical quantities / Thermodynamics / Premarket approval / Medical device / Temperature / Arctic Sun medical device / Medicine / Chemistry / Technology


DEPARTMENT OF HEALTH & HUMAN SERVICES November 14, 2014 Public Health Service
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Document Date: 2014-12-08 09:05:36

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File Size: 155,10 KB

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Company

K140078 Trade / Inspiration Healthcare Limited / /

Continent

Europe / /

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Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

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

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Device Evaluation Center for Devices and Radiological Health Abbreviated / office of Device Evaluation / Cardiovascular Devices Office / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH’s office of Surveillance / /

Person

Bram D. Zuckerman / Silver Spring / Earl Shilton / Wayne Iddon / Earl Shilton Leicester / /

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Position

Manager Gildor House / Regulatory Affairs Manager / Director Division / /

Product

Sterile Water / Federal Food / /

ProvinceOrState

Maryland / /

Technology

radiation / heat transfer / /

URL

http /

SocialTag