SG Lanset I, SG Lancets, Soft Lancets— 510(k) K230712

Name: FDA 510(k) clearance K230712
Creator: U.S. Food and Drug Administration
Published: 2023-12-06

Substantially Equivalent

Sewon Medical Co.

FDA 510(k) clearance K230712 for SG Lanset I, SG Lancets, Soft Lancets, Substantially Equivalent on 2023-12-06. Applicant: Sewon Medical Co.. Device class: 2.

Clearance details

Applicant: Sewon Medical Co.
Product code: Code QRK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2023-03-15
Decision date: 2023-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan-Si, 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.