510(k) K210103

SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX by Lifelong Meditech Private Limited — Product Code FMF

K210103 is an FDA 510(k) premarket notification submitted by Lifelong Meditech Private Limited for the device "SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX". The FDA issued a decision of Substantially Equivalent on July 16, 2021. 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 16, 2021
Date Received
January 14, 2021
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