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510(k) K232781

Safety Sliding Blood Collection Set by Jiangsu Caina Medical Co.,Ltd — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2024
Date Received
September 11, 2023
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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  • K210217 — Needleless Connector (May 17, 2021)
  • K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion Set (April 7, 2021)

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