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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 K130419
Device Name PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Original Applicant
GENORAY CO., LTD.
1073 n. batavia st
orange,  CA  92867
Original Contact jae kim
Regulation Number872.1800
Classification Product Code
MUH  
Date Received02/19/2013
Decision Date 11/06/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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