FDA 510(k) Application Details - K010448

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K010448
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	HORIZONS INTL. CORP. 287 MONTERREY ST. PONCE, PR 00732 US Other 510(k) Applications for this Company
Contact	RAFIC SALEH 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	02/15/2001
Decision Date	05/16/2001
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