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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 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
Correspondent Contact KENNETH B HERLAND
Regulation Number878.3300
Classification Product Code
FTM  
Date Received05/24/2011
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
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