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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 K101517
Device Name SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
Applicant
Sedecal., Sa.
8870 Ravello Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM, P.E.
Correspondent
Sedecal., Sa.
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM, P.E.
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received06/02/2010
Decision Date 08/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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