FDA 510(k) Application Details - K034039

Device Classification Name Mesh, Surgical

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510(K) Number K034039
Device Name Mesh, Surgical
Applicant COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE, IN 47906-1076 US
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Contact MARK BLEYER
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 12/29/2003
Decision Date 02/18/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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