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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 K123976
Device Name NOBELCLINICIAN
Applicant
Nobel Biocare AB
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Applicant Contact PHUONG NGUYEN
Correspondent
Nobel Biocare AB
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact PHUONG NGUYEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/26/2012
Decision Date 03/26/2013
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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