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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 K021107
Device Name FORTAFLEX SURGICAL SLING
Applicant
ORGANOGENESIS, INC.
150 dan rd.
canton,  MA  02021
Contact michael l sabolinski
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/05/2002
Decision Date 05/15/2002
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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