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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, collagen
510(k) Number K011026
Device Name FORTADERM WOUND DRESSING
Applicant
ORGANOGENESIS, INC.
150 DAN RD.
canton,  MA  02021
Applicant Contact patrick r bilbo
Correspondent
ORGANOGENESIS, INC.
150 DAN RD.
canton,  MA  02021
Correspondent Contact patrick r bilbo
Classification Product Code
KGN  
Date Received04/04/2001
Decision Date 06/13/2001
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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