S200, S300— 510(k) K133412

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K133412 for S200, S300, Substantially Equivalent on 2015-01-08. Applicant: Cefla S.C.. Device class: 1.

Clearance details

Applicant: Cefla S.C.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2013-11-07
Decision date: 2015-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
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.