FDA 510(k) Application Details - K980919

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K980919
Device Name	Catheter, Retention Type, Balloon
Applicant	FORTUNE MEDICAL INSTRUMENT CORP. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	KAREN U SALINAS 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	03/11/1998
Decision Date	03/31/1998
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