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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K102102
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
JAK  
Date Received07/27/2010
Decision Date 03/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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