FDA 510(k) Application Details - K193612

Device Classification Name	Tube, Gastro-Enterostomy   More FDA Info for this Device
510(K) Number	K193612
Device Name	Tube, Gastro-Enterostomy
Applicant	Applied Medical Technology, Inc. 8006 Katherine Blvd. Brecksville, OH 44141 US Other 510(k) Applications for this Company
Contact	Joy Tubero 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	12/26/2019
Decision Date	03/12/2020
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