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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 K121410
Device Name DRAGON LW
Original Applicant
SEDECAL SA
8870 ravello st
naples,  FL  34114
Original Contact daniel kamm
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received05/11/2012
Decision Date 08/02/2012
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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