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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cranial surgical planning and instrument guides
510(k) Number K151285
Device Name VSP Cranial System
Applicant
3D Systems, Inc.
17301 West Colfax Avenue, Suite 300
Golden,  CO  80401
Applicant Contact Kim Torluemke
Correspondent
3D Systems, Inc.
17301 West Colfax Avenue, Suite 300
Golden,  CO  80401
Correspondent Contact Kim Torluemke
Regulation Number882.4310
Classification Product Code
PPT  
Date Received05/14/2015
Decision Date 09/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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