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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 K063283
Device Name DEFINIUM 5000 X-RAY SYSTEM
Applicant
SEDECAL S.A.
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
SEDECAL S.A.
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
KPR  
Date Received10/30/2006
Decision Date 11/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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