FDA 510(k) Application Details - K082882

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K082882
Device Name	Needle, Fistula
Applicant	JMS NORTH AMERICA CORP. 55 NORTHERN BLVD. , SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	MARIA F GRIFFIN 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	09/30/2008
Decision Date	01/21/2009
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