510(k) K223499

Three Way Stop Cock by M/S Romsons International — Product Code FMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2023
Date Received
November 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type