FDA 510(k) Application Details - K973076

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K973076
Device Name	Catheter, Retention Type, Balloon
Applicant	UNOMEDICAL SDN BHD POST OFFICE BOX 1108 ELFERS, FL 34680 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	08/18/1997
Decision Date	09/16/1998
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