FORTADERM WOUND DRESSING


Device Classification Name

dressing, wound, collagen

510(k) Number K011026
Device Name FORTADERM WOUND DRESSING
Original Applicant
ORGANOGENESIS, INC.
150 dan rd.
canton, 
MA 
02021

Original Contact patrick r bilbo
Classification Product Code
KGN  
Date Received 04/04/2001
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