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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dressing, wound, collagen
510(k) Number K113866
Device Name PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
Original Applicant
BRENNEN MEDICAL, LLC
1290 hammond rd.
st. paul,  MN  55110
Original Contact kenneth b herland
Classification Product Code
KGN  
Date Received12/30/2011
Decision Date 03/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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