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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K113807
Device Name DEXERYL CREAM
Applicant
Pierre Fabre Medical Devices
1129 Twentieth St., Nw., Suite 600
Washington,  DC  20036
Applicant Contact DIANE MANDELL HORWITZ
Correspondent
Pierre Fabre Medical Devices
1129 Twentieth St., Nw., Suite 600
Washington,  DC  20036
Correspondent Contact DIANE MANDELL HORWITZ
Classification Product Code
FRO  
Date Received12/23/2011
Decision Date 03/07/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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