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510(k) K212805

SteriCap Mini Needle and Standard Needles by Ocuject, LLC — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2021
Date Received
September 2, 2021
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 Ocuject, LLC

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  • K230959 — VitreJect® Needle; OcuSafe® Needle (September 14, 2023)
  • K230372 — VitreJect Syringe (September 8, 2023)
  • K212544 — MiniLoad Syringe (October 13, 2021)
  • K202432 — MiniLoad Syringe (February 19, 2021)
  • K170768 — Mini Needle (July 10, 2017)

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