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510(k) K232165

Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles by Berpu Medical Technology Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2024
Date Received
July 21, 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

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  • K180417 — Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for (August 9, 2018)
  • K162180 — Disposable Insulin Syringe (December 29, 2016)

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