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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 K133271
Device Name OPTEO, VIDEOGRAPH HD
Applicant
Owandy
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
Owandy
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number872.1800
Classification Product Code
MUH  
Date Received10/24/2013
Decision Date 04/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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