UNITEK PALATAL BAR— 510(k) K812239

Substantially Equivalent

Unitek Corp.

FDA 510(k) clearance K812239 for UNITEK PALATAL BAR, Substantially Equivalent on 1981-09-21. Applicant: Unitek Corp.. Device class: 1.

Clearance details

Applicant: Unitek Corp.
Product code: Code DYT
Device class: Class 1
Regulation: 21 CFR 872.5525
Advisory panel: Dental
Date received: 1981-08-11
Decision date: 1981-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.