FDA 510(k) Application Details - K151503

Device Classification Name	More FDA Info for this Device
510(K) Number	K151503
Device Name	NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
Applicant	GBUK Enteral Limited Blackwood Hall Business Park, North Duffield Selby YO85DD GB Other 510(k) Applications for this Company
Contact	Mark Thompson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2015
Decision Date	04/05/2016
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