PORCINE SURGICAL MESH; DERMAL MATRIX


Device Classification Name

mesh, surgical

510(k) Number K081272
Device Name PORCINE SURGICAL MESH; DERMAL MATRIX
Applicant
BRENNEN MEDICAL, LLC
1290 hammond rd.
st. paul, 
MN 
55110

Applicant Contact kenneth b herland
Correspondent
BRENNEN MEDICAL, LLC
1290 hammond rd.
st. paul, 
MN 
55110

Correspodent Contact kenneth b herland
Regulation Number 878.3300
Classification Product Code
FTM  
Date Received 05/05/2008
Decision Date 07/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes

Recalls CDRH Recalls