FDA 510(k) Application Details - K944673

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K944673
Device Name	Catheter, Retention Type, Balloon
Applicant	REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE PALM HARBOR, FL 34682-2308 US Other 510(k) Applications for this Company
Contact	PATRICK J LAMB Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/1994
Decision Date	04/10/1996
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