Myray- HYPERION X5— 510(k) K152162

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K152162 for Myray- HYPERION X5, Substantially Equivalent on 2015-12-24. Applicant: Cefla S.C.. Device class: 2.

Clearance details

Applicant: Cefla S.C.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2015-08-03
Decision date: 2015-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola (Bo), 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.