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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, polymeric
510(K) Number K040787
Device Name MODIFICATION TO SURGICAL MESH POLYMERIC
Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific pl.
natick,  MA  01760 1537
Contact janet a mcgrath
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/01/2004
Decision Date 04/14/2004
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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