FDA 510(k) Application Details - K210782

Device Classification Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve   More FDA Info for this Device
510(K) Number	K210782
Device Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant	Outset Medical, Inc. 3052 Orchard Drive San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Jennifer Mascioli-Tudor Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2021
Decision Date	11/26/2021
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