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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K121132
Device Name EZSENSOR P DIGITAL INTRAORAL SENSOR
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 Number892.1680
Classification Product Code
MQB  
Date Received04/13/2012
Decision Date 05/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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