ArgenZ HT+— 510(k) K190079

Substantially Equivalent

The Argen Corporation

FDA 510(k) clearance K190079 for ArgenZ HT+, Substantially Equivalent on 2019-04-12. Applicant: The Argen Corporation. Device class: 2.

Clearance details

Applicant: The Argen Corporation
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2019-01-16
Decision date: 2019-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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