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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
510(k) Number K040868
Device Name SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
Applicant
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE,  MA  02142
Applicant Contact MICHAEL G HALPIN
Correspondent
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE,  MA  02142
Correspondent Contact MICHAEL G HALPIN
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/02/2004
Decision Date 06/04/2004
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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