I-MAX TOUCH— 510(k) K083057

Substantially Equivalent

Owandy

FDA 510(k) clearance K083057 for I-MAX TOUCH, Substantially Equivalent on 2009-06-02. Applicant: Owandy. Device class: 2.

Clearance details

Applicant: Owandy
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2008-10-14
Decision date: 2009-06-02
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.