FDA 510(k) Application Details - K190084

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K190084
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	Cook Incorporated 750 Daniels Way Bloomington, IN 47404 US Other 510(k) Applications for this Company
Contact	Paul Meyer 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	01/17/2019
Decision Date	10/11/2019
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