FDA 510(k) Application Details - K090688

Device Classification Name	More FDA Info for this Device
510(K) Number	K090688
Device Name	COOK UROLOGICAL GRAFT
Applicant	COOK BIOTECH, INC. 1425 INNOVATION PLACE WEST LAFAYETTE, IN 47906-1000 US Other 510(k) Applications for this Company
Contact	MARY A FADERAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2009
Decision Date	07/10/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review