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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 K102259
Device Name DENTAL 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 Received08/10/2010
Decision Date 02/18/2011
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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