G7, Dental Operative Unit and Accessories— 510(k) K213749

Name: FDA 510(k) clearance K213749
Creator: U.S. Food and Drug Administration
Published: 2023-04-03

Substantially Equivalent

Shinhung Company, Ltd.

FDA 510(k) clearance K213749 for G7, Dental Operative Unit and Accessories, Substantially Equivalent on 2023-04-03. Applicant: Shinhung Company, Ltd.. Device class: 1.

Clearance details

Applicant: Shinhung Company, Ltd.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2021-11-30
Decision date: 2023-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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