Small Volume 0.2mL Syringe— 510(k) K250138

Name: FDA 510(k) clearance K250138
Creator: U.S. Food and Drug Administration
Published: 2025-04-02

Substantially Equivalent

Prosum Medical Limited

FDA 510(k) clearance K250138 for Small Volume 0.2mL Syringe, Substantially Equivalent on 2025-04-02. Applicant: Prosum Medical Limited. Device class: 2.

Clearance details

Applicant: Prosum Medical Limited
Product code: Code QNQ
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2025-01-17
Decision date: 2025-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uxbridge, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.