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510(k) K213535

Sterile Safety Hypodermic Needles for Single Use by Zhejiang Kangkang Medical-Devices Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2022
Date Received
November 5, 2021
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 Zhejiang Kangkang Medical-Devices Co., Ltd.

  • K210229 — Sterile Auto-Disable Syringes with/without Needle for Single Use (February 15, 2022)
  • K210232 — Sterile Hypodermic Needles for Single Use (September 23, 2021)
  • K210227 — Sterile syringe for single use with/without needle (September 10, 2021)

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