Promisemed Safety Huber Needle— 510(k) K230715

Name: FDA 510(k) clearance K230715
Creator: U.S. Food and Drug Administration
Published: 2023-06-08

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K230715 for Promisemed Safety Huber Needle, Substantially Equivalent on 2023-06-08. Applicant: Promisemed Hangzhou Meditech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code PTI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2023-03-15
Decision date: 2023-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

Download summary PDF View on FDA.gov ↗

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