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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 K061711
Device Name OASIS WOUND MATRIX
Original Applicant
COOK BIOTECH, INC.
1425 innovation place
west lafayette,  IN  47906 1000
Original Contact perry w guinn
Classification Product Code
KGN  
Date Received06/19/2006
Decision Date 07/19/2006
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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