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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, Stationary
510(k) Number K090238
Device Name SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
Applicant
Sedecal., Sa.
333 Milford Rd.
Deerfield,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Sedecal., Sa.
333 Milford Rd.
Deerfield,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number892.1680
Classification Product Code
KPR  
Date Received02/02/2009
Decision Date 02/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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