FDA 510(k) Application Details - K160787

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K160787
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	SYNCRO MEDICAL INNOVATIONS, INC. 515 Mulberry Street, Suite 200 Macon, GA 31201 US Other 510(k) Applications for this Company
Contact	Sabry Gabriel 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	03/22/2016
Decision Date	08/09/2016
Decision	SEKD - SUBST EQUIV - KIT WITH DRUGS
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