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510(k) K250658

SureFine Pen Needle by Shina Med Corporation — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2025
Date Received
March 5, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Shina Med Corporation

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  • K210848 — Sure-Fine Insulin Syringes (March 1, 2022)
  • 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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