MOTIFMESH SOFT TISSUE PATCH

Mesh, Surgical, Polymeric

PROXY BIOMEDICAL LTD.

The following data is part of a premarket notification filed by Proxy Biomedical Ltd. with the FDA for Motifmesh Soft Tissue Patch.

Pre-market Notification Details

Device IDK050678
510k NumberK050678
Device Name:MOTIFMESH SOFT TISSUE PATCH
ClassificationMesh, Surgical, Polymeric
Applicant PROXY BIOMEDICAL LTD. P.O. BOX 560 Stillwater,  MN  55082
ContactElaine Duncan
CorrespondentElaine Duncan
PROXY BIOMEDICAL LTD. P.O. BOX 560 Stillwater,  MN  55082
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-16
Decision Date2005-05-20
Summary:summary

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