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510(k) K241821

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle by Sol-Millennium Medical, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2024
Date Received
June 24, 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

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  • 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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