FDA 510(k) Application Details - K061222

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K061222
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	MEDI-GLOBE CORP. 110 WEST ORION, SUITE 136 TEMPE, AZ 85283 US Other 510(k) Applications for this Company
Contact	SCOTT KARLER 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	05/02/2006
Decision Date	07/03/2006
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