Aimanfun Lumea Comfort, A-2789/A-3588— 510(k) K212907

Name: FDA 510(k) clearance K212907
Creator: U.S. Food and Drug Administration
Published: 2021-12-02

Substantially Equivalent

Kam Yuen Plastic Products , Ltd.

FDA 510(k) clearance K212907 for Aimanfun Lumea Comfort, A-2789/A-3588, Substantially Equivalent on 2021-12-02. Applicant: Kam Yuen Plastic Products , Ltd.. Device class: 2.

Clearance details

Applicant: Kam Yuen Plastic Products , Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-09-13
Decision date: 2021-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Zhongshan, 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.