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510(k) K210227

Sterile syringe for single use with/without needle by Zhejiang Kangkang Medical-Devices Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2021
Date Received
January 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Zhejiang Kangkang Medical-Devices Co., Ltd.

  • K213535 — Sterile Safety Hypodermic Needles for Single Use (May 13, 2022)
  • K210229 — Sterile Auto-Disable Syringes with/without Needle for Single Use (February 15, 2022)
  • K210232 — Sterile Hypodermic Needles for Single Use (September 23, 2021)

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