PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX


Device Classification Name

mesh, surgical

510(k) Number K111436
Device Name PORCINE SURGICAL MESH, PORCINE 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 05/24/2011
Decision Date 10/14/2011
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

No