FDA 510(k) Application Details - K012153

Device Classification Name	Catheter, Suprapubic (And Accessories)   More FDA Info for this Device
510(K) Number	K012153
Device Name	Catheter, Suprapubic (And Accessories)
Applicant	CIRCON VIDEO 6500 HOLLISTER AVE. SANTA BARBARA, CA 93117-3019 US Other 510(k) Applications for this Company
Contact	WAYNE B STGRNER Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	KOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2001
Decision Date	09/19/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review