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510(k) K242099

Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle by Sol-Millennium Medical, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2024
Date Received
July 18, 2024
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

Other clearances by Sol-Millennium Medical, Inc.

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  • K220713 — Sol-Guard Auto-disable Syringe (May 4, 2023)
  • K222744 — Sol-M Luer Lock Syringe (October 11, 2022)
  • K213718 — SOL-GUARD Safety Pull Button Collection Set (August 30, 2022)
  • K182146 — Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Ca (December 3, 2018)
  • K163073 — Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder (May 19, 2017)
  • K162030 — 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle (August 19, 2016)
  • K153537 — Sol-M Insulin Syringe, Sol-M TB Syringe (June 17, 2016)

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