FDA 510(k) Application Details - K091257

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K091257
Device Name	Kit, Needle, Biopsy
Applicant	MEDI-GLOBE CORPORATION 110 WEST ORION ST #136 TEMPE, AZ 85283 US Other 510(k) Applications for this Company
Contact	SCOTT KARLER Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2009
Decision Date	05/08/2009
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	Y
Expedited Review