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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 K121412
Device Name PAX-FLEX3D, PHT-7000
Applicant
VATECH Co., Ltd.
12946 Kimberley Ln.
Houston,  TX  77079
Applicant Contact DAVE KIM
Correspondent
VATECH Co., Ltd.
12946 Kimberley Ln.
Houston,  TX  77079
Correspondent Contact DAVE KIM
Regulation Number892.1750
Classification Product Code
OAS  
Date Received05/11/2012
Decision Date 06/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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