VISTEO— 510(k) K093105

Substantially Equivalent

Owandy

FDA 510(k) clearance K093105 for VISTEO, Substantially Equivalent on 2010-10-18. Applicant: Owandy. Device class: 2.

Clearance details

Applicant: Owandy
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2009-10-01
Decision date: 2010-10-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Roswell, GA, 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.