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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 K173619
Device Name Mimics inPrint
Applicant
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Oliver Clemens
Correspondent
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Oliver Clemens
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/22/2017
Decision Date 03/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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