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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K113360
Device Name MEDICAL IMAGE PROCESSING UNIT
Applicant
Humanray Co,Ltd
12946 Kimberley Ln.
Houston,  TX  77079
Applicant Contact DAVE KIM
Correspondent
Humanray Co,Ltd
12946 Kimberley Ln.
Houston,  TX  77079
Correspondent Contact DAVE KIM
Regulation Number872.1810
Classification Product Code
EAP  
Subsequent Product Code
MQB  
Date Received11/14/2011
Decision Date 02/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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