FDA 510(k) Application Details - K021142

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K021142
Device Name	Catheter, Retention Type, Balloon
Applicant	FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG TAIPEI HSIEN 252 TW Other 510(k) Applications for this Company
Contact	TYLER WANG 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	04/09/2002
Decision Date	10/01/2002
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