510(k) K222925

Hypodermic Syringes & Needle by Lifelong Meditech Private Limited — Product Code FMF

K222925 is an FDA 510(k) premarket notification submitted by Lifelong Meditech Private Limited for the device "Hypodermic Syringes & Needle". The FDA issued a decision of Substantially Equivalent on July 18, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Lifelong Meditech Private Limited has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2023
Date Received
September 26, 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