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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K103290
Device Name EDLEN IMAGING - GEMINI DUSB
Applicant
Edlen Imaging, LLC
3707 N 7th St.
Suite 125
Phoenix,  AZ  85014
Applicant Contact FELIX HOVSEPIAN
Correspondent
Edlen Imaging, LLC
3707 N 7th St.
Suite 125
Phoenix,  AZ  85014
Correspondent Contact FELIX HOVSEPIAN
Regulation Number872.1800
Classification Product Code
MUH  
Date Received11/08/2010
Decision Date 09/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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