510(k) K222744

Sol-M Luer Lock Syringe by Sol-Millennium Medical, Inc. — Product Code FMF

K222744 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "Sol-M Luer Lock Syringe". The FDA issued a decision of Substantially Equivalent on October 11, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2022
Date Received
September 12, 2022
Clearance Type
Special
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