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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 K110300
Device Name SIMPLANT 2011
Applicant
Materialise Dental Nv
Technologielaan 15
Leuven,  BE 3001
Applicant Contact PETER VANDEPUT
Correspondent
Materialise Dental Nv
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact PETER VANDEPUT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/02/2011
Decision Date 07/01/2011
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
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