FDA 510(k) Application Details - K122816

Device Classification Name	Endoscopic Guidewire, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K122816
Device Name	Endoscopic Guidewire, Gastroenterology-Urology
Applicant	WILSON-COOK MEDICAL INC. 4900 Bethania Station Rd Winston Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	DORIS A HAWKS 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	09/14/2012
Decision Date	10/09/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review