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510(k) K152877

SureFine Pen Needle by Shina Med Corporation — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2016
Date Received
September 30, 2015
Clearance Type
Traditional
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)

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  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
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