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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K123332
Device Name NAOMI-CT
Applicant
LK CONSULTING GROUP
1515 E KATELLA AVE. UNIT 2115
ANAHEIM,  CA  92805
Applicant Contact Priscilla Chung
Correspondent
LK CONSULTING GROUP
1515 E KATELLA AVE. UNIT 2115
ANAHEIM,  CA  92805
Correspondent Contact Priscilla Chung
Regulation Number892.1750
Classification Product Code
OAS  
Date Received10/26/2012
Decision Date 07/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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