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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 K090322
Device Name EASY MOVING PLUS, SM-XXHF-YY
Applicant
SEDECAL S.A.
333 MILFORD ROAD
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
SEDECAL S.A.
333 MILFORD ROAD
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number892.1720
Classification Product Code
IZL  
Date Received02/09/2009
Decision Date 03/17/2009
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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