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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 K141570
Device Name IMPLANT STUDIO
Applicant
3Shape Medical A/S
Holmens Kanal 7
Copenhagen,  DK Dk-1060
Applicant Contact HANNE NIELSEN
Correspondent
3Shape Medical A/S
Holmens Kanal 7
Copenhagen,  DK Dk-1060
Correspondent Contact HANNE NIELSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/12/2014
Decision Date 10/31/2014
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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