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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 K051647
FOIA Releasable 510(k) K051647
Device Name FORTADERM ANTIMICROBIAL WOUND DRESSING
Applicant
Organogenesis, Inc.
150 Dan Rd.
Canton,  MA  02021
Applicant Contact PATRICK BILBO
Correspondent
Organogenesis, Inc.
150 Dan Rd.
Canton,  MA  02021
Correspondent Contact PATRICK BILBO
Classification Product Code
FRO  
Date Received06/21/2005
Decision Date 11/08/2005
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
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