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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 K011027
Device Name FORTAFLEX SURGICAL SLING
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
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/05/2001
Decision Date 05/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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