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510(k) K210848

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2022
Date Received
March 22, 2021
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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