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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 K033849
Device Name SIMPLANT SYSTEM
Applicant
Materialise N.V
15 Technologielaan
Leuven,  BE 3001
Applicant Contact CARL VAN LIERDE
Correspondent
Materialise N.V
15 Technologielaan
Leuven,  BE 3001
Correspondent Contact CARL VAN LIERDE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/11/2003
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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