Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products— 510(k) K151400

Clearance details

Applicant

Jk Holding GmbH

Product code

Code LEJ

Device class

Class 2

Regulation

21 CFR 878.4635

Advisory panel

General, Plastic Surgery

Date received

2015-05-26

Decision date

2015-09-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Windhagen, DE

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