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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 K111725
Device Name MOBILEDIAGNOST WDR
Applicant
Sedecal., Sa.
409 Woodridge Dr.
Seneca,  SC  29672
Applicant Contact JENNIFER CARTLEDGE
Correspondent
Sedecal., Sa.
409 Woodridge Dr.
Seneca,  SC  29672
Correspondent Contact JENNIFER CARTLEDGE
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received06/20/2011
Decision Date 07/19/2011
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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