PORCINE SURGICAL MESH; DERMAL MATRIX

Mesh, Surgical

BRENNEN MEDICAL, LLC

The following data is part of a premarket notification filed by Brennen Medical, Llc with the FDA for Porcine Surgical Mesh; Dermal Matrix.

Pre-market Notification Details

Device IDK081272
510k NumberK081272
Device Name:PORCINE SURGICAL MESH; DERMAL MATRIX
ClassificationMesh, Surgical
Applicant BRENNEN MEDICAL, LLC 1290 HAMMOND RD. St. Paul,  MN  55110
ContactKenneth B Herland
CorrespondentKenneth B Herland
BRENNEN MEDICAL, LLC 1290 HAMMOND RD. St. Paul,  MN  55110
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-05-05
Decision Date2008-07-31
Summary:summary

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