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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact KENNETH B HERLAND
Regulation Number878.3300
Classification Product Code
FTM  
Date Received05/05/2008
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
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