C-U2— 510(k) K062897

Substantially Equivalent

Cefla S.C.R.L.

FDA 510(k) clearance K062897 for C-U2, Substantially Equivalent on 2006-12-14. Applicant: Cefla S.C.R.L.. Device class: 1.

Clearance details

Applicant: Cefla S.C.R.L.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2006-09-27
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ormond Beach, FL, 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.