SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH

Mesh, Surgical, Polymeric

GENZYME CORPORATION

The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Sepramesh Ip Bioresorbable Coating/permanent Mesh.

Pre-market Notification Details

Device IDK053066
510k NumberK053066
Device Name:SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
ClassificationMesh, Surgical, Polymeric
Applicant GENZYME CORPORATION 55 CAMBRIDGE PARKWAY Cambridge,  MA  02142
ContactLisa D Crockett
CorrespondentLisa D Crockett
GENZYME CORPORATION 55 CAMBRIDGE PARKWAY Cambridge,  MA  02142
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-01
Decision Date2005-12-19
Summary:summary

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