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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
Predetermined Change
Control Plan Authorized		 No
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