ADX4000W— 510(k) K134055

Substantially Equivalent

Dexcowin Co., Ltd.

FDA 510(k) clearance K134055 for ADX4000W, Substantially Equivalent on 2014-05-09. Applicant: Dexcowin Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dexcowin Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2013-12-31
Decision date: 2014-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Ormond Beach, FL, US

Download summary PDF View on FDA.gov ↗

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