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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
Original Applicant
ORGANOGENESIS, INC.
150 dan rd.
canton,  MA  02021
Original Contact patric bilbo
Regulation Number878.3300
Classification Product Code
FTM  
Date Received01/07/2002
Decision Date 03/18/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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