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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopaedic Surgical Planning And Instrument Guides
510(k) Number K132290
Device Name SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
Applicant
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Applicant Contact OLIVER CLEMENS
Correspondent
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact OLIVER CLEMENS
Regulation Number888.3030
Classification Product Code
PBF  
Date Received07/23/2013
Decision Date 04/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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