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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 K101793
Device Name MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
Applicant
Derma Sciences, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact RONALD S WARREN
Correspondent
Derma Sciences, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact RONALD S WARREN
Classification Product Code
FRO  
Date Received06/28/2010
Decision Date 02/22/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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