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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 STREET
CAMBRIDGE,  MA  02142 -1562
Applicant Contact JOHN A DELUCIA
Correspondent
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE,  MA  02142 -1562
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
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