EzRay Air W— 510(k) K163705

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K163705 for EzRay Air W, Substantially Equivalent on 2017-01-24. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2016-12-29
Decision date: 2017-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-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.