LED CURING LIGHT, MODEL GT-1500— 510(k) K091887

Name: FDA 510(k) clearance K091887
Creator: U.S. Food and Drug Administration
Published: 2009-09-18

Substantially Equivalent

Monitex Industrial Co., Ltd.

FDA 510(k) clearance K091887 for LED CURING LIGHT, MODEL GT-1500, Substantially Equivalent on 2009-09-18. Applicant: Monitex Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Monitex Industrial Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2009-06-24
Decision date: 2009-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San-Chung City, TW

Download summary PDF View on FDA.gov ↗

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