FDA 510(k) Application Details - K150304

Device Classification Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve   More FDA Info for this Device
510(K) Number	K150304
Device Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant	Oxyless Ltd Third Floor, Bewlay House, 2 Swallow Place London GB Other 510(k) Applications for this Company
Contact	Bob Duffy Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2015
Decision Date	02/24/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review