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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
Applicant
Genoray Co., Ltd.
1073 N. Batavia St.
Orange,  CA  92867
Applicant Contact JAE KIM
Correspondent
Genoray Co., Ltd.
1073 N. Batavia St.
Orange,  CA  92867
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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