Ergoline Sunrise 7200 Hybrid Technology— 510(k) K183539

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

2018-12-20

Decision date

2019-04-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Windhagen, DE

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