Q-LITE 75 LIGHT CURE UNIT— 510(k) K991865

Name: FDA 510(k) clearance K991865
Creator: U.S. Food and Drug Administration
Published: 1999-07-20

Substantially Equivalent

Rolence Enterprise Co. , Ltd.

FDA 510(k) clearance K991865 for Q-LITE 75 LIGHT CURE UNIT, Substantially Equivalent on 1999-07-20. Applicant: Rolence Enterprise Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Rolence Enterprise Co. , Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 1999-06-01
Decision date: 1999-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chungli 320, 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.