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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 K073449
Device Name SURGICASE
Applicant
Materialise NV
15 Technologielaan
Leuven,  BE 3001
Applicant Contact MIEKE JANSSEN
Correspondent
Materialise NV
15 Technologielaan
Leuven,  BE 3001
Correspondent Contact MIEKE JANSSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/2007
Decision Date 04/16/2008
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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