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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 K123419
Device Name EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
Applicant
AFP IMAGING CORP.
8870 RAVELLO CT.
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM, P.E.
Correspondent
AFP IMAGING CORP.
8870 RAVELLO CT.
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM, P.E.
Regulation Number872.1800
Classification Product Code
MUH  
Date Received11/06/2012
Decision Date 12/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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