PROPATCH SOFT TISSUE REPAIR MATRIX

Mesh, Surgical

CRYOLIFE, INC.

The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Propatch Soft Tissue Repair Matrix.

Pre-market Notification Details

Device IDK101587
510k NumberK101587
Device Name:PROPATCH SOFT TISSUE REPAIR MATRIX
ClassificationMesh, Surgical
Applicant CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw,  GA  30144
ContactBryan Brosseau
CorrespondentBryan Brosseau
CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw,  GA  30144
Product CodeFTM  
Subsequent Product CodeOWY
Subsequent Product CodeOXB
Subsequent Product CodeOXE
Subsequent Product CodeOXH
Subsequent Product CodeOXK
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-07
Decision Date2010-09-16
Summary:summary

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