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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 K102196
Device Name COMPUTED TOMOGRAPHY X-RAY SYSTEM
Applicant
Vatech Co., Ltd.
333 Meadowlands Pkwy.,
#303
Secaucus,  NJ  07094
Applicant Contact DAVE KIM
Correspondent
Vatech Co., Ltd.
333 Meadowlands Pkwy.,
#303
Secaucus,  NJ  07094
Correspondent Contact DAVE KIM
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/29/2010
Decision Date 03/25/2011
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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