Cruxcan (CRX-1000)— 510(k) K183637

Substantially Equivalent

Cruxell Corp.

FDA 510(k) clearance K183637 for Cruxcan (CRX-1000), Substantially Equivalent on 2019-02-12. Applicant: Cruxell Corp.. Device class: 2.

Clearance details

Applicant: Cruxell Corp.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2018-12-26
Decision date: 2019-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, 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.