UV PHOTOTHERAPY— 510(k) K132643

Name: FDA 510(k) clearance K132643
Creator: U.S. Food and Drug Administration
Published: 2014-01-30

Substantially Equivalent

Xuzhou Kernel Medical Equipment Co., Ltd.

FDA 510(k) clearance K132643 for UV PHOTOTHERAPY, Substantially Equivalent on 2014-01-30. Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2013-08-26
Decision date: 2014-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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