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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 K994328
Device Name SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
Applicant
Genzyme Corp.
500 Kendall St.
Cambridge,  MA  02142
Applicant Contact JOHN A DELUCIA
Correspondent
Genzyme Corp.
500 Kendall St.
Cambridge,  MA  02142
Correspondent Contact JOHN A DELUCIA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/22/1999
Decision Date 03/02/2000
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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