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510(k) K220900

Safety Blood Collection Needles with/without Needle Holder by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2022
Date Received
March 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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  • K222141 — Safety Blood Collection Needle (Without Needle Holder) (October 21, 2022)
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  • K214075 — Safety Blood Collection / Infusion Set (with/without needle holder), Blood Colle (April 12, 2022)
  • K211555 — Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe (October 18, 2021)
  • K202188 — Safety Blood Collection Sets for Single Use (February 19, 2021)

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