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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
Model SPSL W4 AND SPSL W8
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 Received05/23/2012
Decision Date 08/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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