FDA 510(k) Application Details - K012977

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K012977
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	ENDO-THERAPEUTICS, INC. 1183 CEDAR ST. SAFETY HARBOR, FL 34695-2908 US Other 510(k) Applications for this Company
Contact	TODD ADKISSON 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	09/05/2001
Decision Date	11/02/2001
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