FDA 510(k) Application Details - K020654

Device Classification Name	More FDA Info for this Device
510(K) Number	K020654
Device Name	STRATASIS SLING KIT
Applicant	COOK BIOTECH, INC. 3055 KENT AVE. WEST LAFAYETTE, IN 47906-1076 US Other 510(k) Applications for this Company
Contact	MARK BLEYER 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	02/28/2002
Decision Date	04/09/2002
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