ANESTHESIA INJECTION TOOL SET— 510(k) K113247

Name: FDA 510(k) clearance K113247
Creator: U.S. Food and Drug Administration
Published: 2012-03-27

Substantially Equivalent

Ki Works Co., Ltd.

FDA 510(k) clearance K113247 for ANESTHESIA INJECTION TOOL SET, Substantially Equivalent on 2012-03-27. Applicant: Ki Works Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ki Works Co., Ltd.
Product code: Code EJI
Device class: Class 2
Regulation: 21 CFR 872.6770
Advisory panel: Dental
Date received: 2011-11-02
Decision date: 2012-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongsan-Dong, Daejeon, KR

Download summary PDF View on FDA.gov ↗

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