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510(k) K220713

Sol-Guard Auto-disable Syringe by Sol-Millennium Medical, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2023
Date Received
March 11, 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

Other clearances by Sol-Millennium Medical, Inc.

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  • K241821 — Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle (September 20, 2024)
  • 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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