SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH

Mesh, Surgical

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Sepramesh Ip Bioresorbable Barrier - Permanent Mesh.

Pre-market Notification Details

Device IDK040868
510k NumberK040868
Device Name:SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
ClassificationMesh, Surgical
Applicant GENZYME CORP. 500 KENDALL STREET Cambridge,  MA  02142
ContactMichael G Halpin
CorrespondentMichael G Halpin
GENZYME CORP. 500 KENDALL STREET Cambridge,  MA  02142
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-02
Decision Date2004-06-04
Summary:summary

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