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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, mobile
510(k) Number K100400
Device Name PRESTODR PORTABLE
Original Applicant
CMT MEDICAL TECHNOLOGIES, LTD.
hacarmel st building 7/2
p.o.b. 111
yoqneam ilit,  IL 20692
Original Contact shlomi dines
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received02/16/2010
Decision Date 04/22/2010
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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