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510(k) K191531

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2019
Date Received
June 10, 2019
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

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

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