SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)— 510(k) K230759

Name: FDA 510(k) clearance K230759
Creator: U.S. Food and Drug Administration
Published: 2023-06-13

Substantially Equivalent

Bosungmeditech Co., Ltd.

FDA 510(k) clearance K230759 for SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro), Substantially Equivalent on 2023-06-13. Applicant: Bosungmeditech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bosungmeditech Co., Ltd.
Product code: Code QRK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2023-03-20
Decision date: 2023-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.