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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, fluoroscopic, image-intensified
510(k) Number K110785
Model DREX-KL80
Device Name KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
Original Applicant
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 michelle dr
tustin,  CA  92780
Original Contact paul biggins
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/21/2011
Decision Date 05/27/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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