Surgical Drive System (Model: ES70, ES90, E8)— 510(k) K240340

Name: FDA 510(k) clearance K240340
Creator: U.S. Food and Drug Administration
Published: 2024-07-18

Substantially Equivalent

Guangdong Jinme Medical Technology Co., Ltd.

FDA 510(k) clearance K240340 for Surgical Drive System (Model: ES70, ES90, E8), Substantially Equivalent on 2024-07-18. Applicant: Guangdong Jinme Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangdong Jinme Medical Technology Co., Ltd.
Product code: Code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2024-02-05
Decision date: 2024-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

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