EDLEN IMAGING - GEMINI DUSB— 510(k) K103290

Substantially Equivalent

Edlen Imaging, LLC

FDA 510(k) clearance K103290 for EDLEN IMAGING - GEMINI DUSB, Substantially Equivalent on 2011-09-19. Applicant: Edlen Imaging, LLC. Device class: 2.

Clearance details

Applicant: Edlen Imaging, LLC
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2010-11-08
Decision date: 2011-09-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Phoenix, AZ, 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.