CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676— 510(k) K942199

Name: FDA 510(k) clearance K942199
Creator: U.S. Food and Drug Administration
Published: 1994-06-02

Substantially Equivalent

Rolence Enterprise Co. , Ltd.

FDA 510(k) clearance K942199 for CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676, Substantially Equivalent on 1994-06-02. 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: 1994-05-05
Decision date: 1994-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chungli, Taiwan, TW

Download summary PDF View on FDA.gov ↗

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