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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 K963226
Device Name SURGICAL FABRICS
Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific pl.
natick,  MA  01760 -1537
Applicant Contact lorraine m hanley
Correspondent
BOSTON SCIENTIFIC CORP.
one boston scientific pl.
natick,  MA  01760 -1537
Correspodent Contact lorraine m hanley
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/19/1996
Decision Date 11/15/1996
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
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