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510(k) K221080

Sterile Safety Hypodermic Needles for Single Use by Sichuan Prius Biotechnology Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2022
Date Received
April 12, 2022
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 Sichuan Prius Biotechnology Co., Ltd.

  • K221078 — Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use (November 21, 2022)
  • K221075 — Infusion Sets for Single Use (November 21, 2022)
  • K221069 — Infusion Sets for Single Use with Needles (November 21, 2022)
  • K221066 — Sterile Hypodermic Needles for Single Use (October 4, 2022)
  • K221068 — Sterile Hypodermic Syringes for Single Use with Needles (October 4, 2022)
  • K221073 — Sterile Hypodermic Syringes for Single Use with Safety Needles (October 4, 2022)
  • K221079 — Sterile Hypodermic Syringes for Single Use (October 4, 2022)
  • K210908 — Surgical Mask (September 26, 2021)

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