FDA 510(k) Application Details - K973170

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K973170
Device Name Dressing, Wound, Collagen
Applicant COOK BIOTECH, INC.
P.O. BOX 2603, 3055 KENT AVE.
WEST LAFAYETTE, IN 47906 US
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Contact NEAL E FEARNOT
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 08/25/1997
Decision Date 04/30/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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