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Technology / Food law / Pharmaceuticals policy / Medical equipment / Medical device / Medical technology / Premarket approval / Federal Food / Drug / and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Health


MAR[removed]Pierre Fabre MEDICAL DEVICES 510(K) SUMMARY
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Document Date: 2012-04-23 00:34:29

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File Size: 135,02 KB

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City

Northwest Washington / /

Company

The Weinberg Group Inc. / K1 13807 Trade / /

Continent

Europe / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

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

MedicalCondition

allergic contact dermatitis / atopic dermatitis / itching / dermatoses / irritant contact dermatitis / irritation / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Division Sign-of Division / Division of Surgical / Orthopedic and Restorative Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /

Person

Diane Horwitz / PIERRE FABRE DEXERYLTM CREAM SUBMITTER / Pierre Fabre / Silver Spring / M. Pascal Lefrangois / /

/

Position

Director / /

Product

Federal Food / device / DEXERYLTM Cream / /

ProvinceOrState

District of Columbia / Maryland / /

Region

Northwest Washington / /

Technology

radiation / /

URL

http /

SocialTag