KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun— 510(k) K191881

Name: FDA 510(k) clearance K191881
Creator: U.S. Food and Drug Administration
Published: 2019-10-28

Substantially Equivalent

Kbl GmbH

FDA 510(k) clearance K191881 for KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun, Substantially Equivalent on 2019-10-28. Applicant: Kbl GmbH. Device class: 2.

Clearance details

Applicant: Kbl GmbH
Product code: Code LEJ
Device class: Class 2
Regulation: 21 CFR 878.4635
Advisory panel: General, Plastic Surgery
Date received: 2019-07-15
Decision date: 2019-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Dernbach, DE

Download summary PDF View on FDA.gov ↗

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