FDA 510(k) Application Details - K964899

Device Classification Name	Catheter, Ureteral, Gastro-Urology   More FDA Info for this Device
510(K) Number	K964899
Device Name	Catheter, Ureteral, Gastro-Urology
Applicant	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	DAVID A OLSON Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/1996
Decision Date	02/07/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review