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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K103136
Device Name SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
Applicant
Materialise N.V
15 Technologielaan
Leuven,  BE 3001
Applicant Contact Alexandra Razzhivina
Correspondent
Materialise N.V
15 Technologielaan
Leuven,  BE 3001
Correspondent Contact Alexandra Razzhivina
Regulation Number872.4760
Classification Product Code
JEY  
Date Received10/25/2010
Decision Date 03/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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