FDA 510(k) Application Details - K150350

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K150350
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	ConvaTec Ltd. Unit 20, First Ave, Deeside Industrial Park Deeside CH5 2NU GB Other 510(k) Applications for this Company
Contact	Clare Williamson Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2015
Decision Date	07/21/2015
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