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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 K103522
Device Name SEDECAL
Applicant
SEDECAL S.A.
8870 RAVELLO
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM, P.E.
Correspondent
SEDECAL S.A.
8870 RAVELLO
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM, P.E.
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/01/2010
Decision Date 01/26/2011
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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