FDA 510(k) Application Details - K043383

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K043383
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	PHYSION, INC. 51 JOHN F. KENNEDY PKWY. SHORT HILLS, NJ 07078-5006 US Other 510(k) Applications for this Company
Contact	ERIC J NEMETH, ESQ. Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2004
Decision Date	10/27/2005
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