510(k) K220184

Pump Alignment Syringe by Jiangsu Caina Medical Co.,Ltd — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2022
Date Received
January 24, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type