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510(k) K250510

Sure-Fine Insulin Syringes by Shina Med Corporation — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2025
Date Received
February 21, 2025
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

Other clearances by Shina Med Corporation

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  • K191531 — Sure-Fine Insulin Syringes (September 6, 2019)
  • K152879 — Sure-Fine Insulin Syringes (September 9, 2016)
  • K152877 — SureFine Pen Needle (June 7, 2016)

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