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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 K063739
Device Name SEPRAMESH, MODEL 5959-1214
Applicant
Genzyme Corporation
500 Kendall St.
Cambridge,  MA  02142
Applicant Contact MATTHEW HIBBERT
Correspondent
Genzyme Corporation
500 Kendall St.
Cambridge,  MA  02142
Correspondent Contact MATTHEW HIBBERT
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/18/2006
Decision Date 01/17/2007
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
Predetermined Change
Control Plan Authorized		 No
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