FDA 510(k) Application Details - K170323

Device Classification Name	Tube, Gastro-Enterostomy   More FDA Info for this Device
510(K) Number	K170323
Device Name	Tube, Gastro-Enterostomy
Applicant	Cook Incorporated 450 Daniels Way, P.O. Box 489 Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Erum B. Nasir Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2017
Decision Date	09/14/2017
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