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510(k) K242632

Verifine® Pen Needles by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2024
Date Received
September 3, 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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  • K230715 — Promisemed Safety Huber Needle (June 8, 2023)
  • K223453 — Insulin Syringe (March 2, 2023)

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  • K250724 — Intraosseous Infusion Needles (July 30, 2025)
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  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
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