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510(k) K233284

Vial Adapter with Filter by Hangzhou Qiantang Longyue Biotechnology Co., Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

  • K233287 — Vent Vial Adapter (July 26, 2024)
  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K222718 — Vial Adapter (March 10, 2023)

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