Disposable Urine Collection Tube— 510(k) K220739

Name: FDA 510(k) clearance K220739
Creator: U.S. Food and Drug Administration
Published: 2022-11-17

Substantially Equivalent

Zhejiang Gongdong Medical Technology Co., Ltd.

FDA 510(k) clearance K220739 for Disposable Urine Collection Tube, Substantially Equivalent on 2022-11-17. Applicant: Zhejiang Gongdong Medical Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Zhejiang Gongdong Medical Technology Co., Ltd.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2022-03-14
Decision date: 2022-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taizhou, CN

Download summary PDF View on FDA.gov ↗

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