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510(k) K152879

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2016
Date Received
September 30, 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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  • K191531 — Sure-Fine Insulin Syringes (September 6, 2019)
  • K152877 — SureFine Pen Needle (June 7, 2016)

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