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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K020049
Device Name FORTAFLEX SURGICAL MESH
Applicant
Organogenesis, Inc.
150 Dan Rd.
Canton,  MA  02021
Applicant Contact PATRIC BILBO
Correspondent
Organogenesis, Inc.
150 Dan Rd.
Canton,  MA  02021
Correspondent Contact PATRIC BILBO
Regulation Number878.3300
Classification Product Code
FTM  
Date Received01/07/2002
Decision Date 03/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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