FDA 510(k) Application Details - K153264

Device Classification Name	Endoscopic Guidewire, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K153264
Device Name	Endoscopic Guidewire, Gastroenterology-Urology
Applicant	MEDI-GLOBE CORPORATION 7850 SOUTH HARDY DRIVE STE. 112 TEMPE, AZ 85284 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	OCY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2015
Decision Date	05/19/2016
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