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510(k) K230959

VitreJect® Needle; OcuSafe® Needle by Ocuject, LLC — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2023
Date Received
April 4, 2023
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 Ocuject, LLC

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  • K230372 — VitreJect Syringe (September 8, 2023)
  • K212544 — MiniLoad Syringe (October 13, 2021)
  • K212805 — SteriCap Mini Needle and Standard Needles (September 30, 2021)
  • K202432 — MiniLoad Syringe (February 19, 2021)
  • K170768 — Mini Needle (July 10, 2017)

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