FDA 510(k) Application Details - K200082

Device Classification Name	More FDA Info for this Device
510(K) Number	K200082
Device Name	BD Univia RightFit Enteral Extension Sets and Transitional Adapters
Applicant	MPS Medical, Inc. 830 Challenger Street, Suite 200 Brea, CA 92821 US Other 510(k) Applications for this Company
Contact	Barry Kazemi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2020
Decision Date	07/30/2020
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