FDA 510(k) Application Details - K013037

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K013037
Device Name	Needle, Fistula
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	876.5540   More FDA Info for this Regulation Number
Classification Product Code	FIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2001
Decision Date	12/07/2001
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