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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 K080315
Device Name DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
Applicant
Derma Sciences, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Derma Sciences, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Classification Product Code
FRO  
Date Received02/06/2008
Decision Date 04/23/2008
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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