ZIMMER COLLAGEN REPAIR PATCH

Mesh, Surgical

TISSUE SCIENCE LABORATORIES, PLC

The following data is part of a premarket notification filed by Tissue Science Laboratories, Plc with the FDA for Zimmer Collagen Repair Patch.

Pre-market Notification Details

Device IDK053562
510k NumberK053562
Device Name:ZIMMER COLLAGEN REPAIR PATCH
ClassificationMesh, Surgical
Applicant TISSUE SCIENCE LABORATORIES, PLC 1141 CLARK STREET, SUITE D Covington,  GA  30014
ContactAngela Bunn
CorrespondentAngela Bunn
TISSUE SCIENCE LABORATORIES, PLC 1141 CLARK STREET, SUITE D Covington,  GA  30014
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-21
Decision Date2006-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884523000573 K053562 000
10884523000566 K053562 000
10884523000269 K053562 000

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