510(k) K201044

CHIRANA Insulin Syringes by Chirana T. Injecta — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2022
Date Received
April 21, 2020
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