RXS 1000— 510(k) K202369

Substantially Equivalent

Rolence Enterprise, Inc.

FDA 510(k) clearance K202369 for RXS 1000, Substantially Equivalent on 2021-09-15. Applicant: Rolence Enterprise, Inc.. Device class: 2.

Clearance details

Applicant: Rolence Enterprise, Inc.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2020-08-19
Decision date: 2021-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan, TW

Download summary PDF View on FDA.gov ↗

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