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510(k) K153537

Sol-M Insulin Syringe, Sol-M TB Syringe by Sol-Millennium Medical, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2016
Date Received
December 10, 2015
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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  • K220713 — Sol-Guard Auto-disable Syringe (May 4, 2023)
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  • 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)

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