X-MIND UNITY— 510(k) K132378

Substantially Equivalent

De Gotzen S.R.L.

FDA 510(k) clearance K132378 for X-MIND UNITY, Substantially Equivalent on 2014-05-30. Applicant: De Gotzen S.R.L.. Device class: 2.

Clearance details

Applicant: De Gotzen S.R.L.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2013-07-31
Decision date: 2014-05-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Olgiate Olona, Varese, IT

Download summary PDF View on FDA.gov ↗

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