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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 K090467
Device Name DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
Applicant
VATECH CO., LTD.
256 NORTH SAM HOUSTON PKWY E.
SUITE 115
HOUSTON,  TX  77060
Applicant Contact VINCENT LEE
Correspondent
VATECH CO., LTD.
256 NORTH SAM HOUSTON PKWY E.
SUITE 115
HOUSTON,  TX  77060
Correspondent Contact VINCENT LEE
Regulation Number892.1750
Classification Product Code
OAS  
Date Received02/23/2009
Decision Date 01/08/2010
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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