FDA 510(k) Application Details - K133763

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K133763
Device Name	Kit, Needle, Biopsy
Applicant	MEDI-GLOBE CORPORATION 110 WEST ORION STREET 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	12/11/2013
Decision Date	05/15/2014
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