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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K053592
Device Name SIMPLANT DR. JAMES
Applicant
Materialise NV
15 Technologielaan
Leuven,  BE 3001
Applicant Contact CARL VAN LIERDE
Correspondent
Materialise NV
15 Technologielaan
Leuven,  BE 3001
Correspondent Contact CARL VAN LIERDE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/23/2005
Decision Date 02/08/2006
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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