APEXUM ABLATOR— 510(k) K082325

Substantially Equivalent

Apexum , Ltd.

FDA 510(k) clearance K082325 for APEXUM ABLATOR, Substantially Equivalent on 2009-04-21. Applicant: Apexum , Ltd.. Device class: 1.

Clearance details

Applicant: Apexum , Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2008-08-14
Decision date: 2009-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or Yehuda, IL

Download summary PDF View on FDA.gov ↗

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