MODIFICATION TO 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 Modification To Motifmesh Soft Tissue Patch.

Pre-market Notification Details

Device IDK052100
510k NumberK052100
Device Name:MODIFICATION TO 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-03
Decision Date2005-08-11
Summary:summary

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