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510(k) K243806

Safety Winged Blood Collection Sets by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2025
Date Received
December 11, 2024
Clearance Type
Special
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

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  • K234124 — Single Use Hemoclips (July 12, 2024)
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  • K230715 — Promisemed Safety Huber Needle (June 8, 2023)
  • K223453 — Insulin Syringe (March 2, 2023)

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