FDA 510(k) Application Details - K992039

Device Classification Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve   More FDA Info for this Device
510(K) Number	K992039
Device Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant	EXELINT INTL. CO. 5840 WEST CENTINELA AVE. LOS ANGELES, CA 90045 US Other 510(k) Applications for this Company
Contact	ARMAND HAMID Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/1999
Decision Date	02/10/2000
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