TotalC-Ram— 510(k) K162960

Substantially Equivalent

Itena Clinical

FDA 510(k) clearance K162960 for TotalC-Ram, Substantially Equivalent on 2017-03-14. Applicant: Itena Clinical. Device class: 2.

Clearance details

Applicant: Itena Clinical
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2016-10-24
Decision date: 2017-03-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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More clearances from Itena Clinical

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