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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K092103
Device Name DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
Applicant
VATECH Co., Ltd.
256 N. Sam Houston Pkwy. E.
Suite 115
Houston,  TX  77060
Applicant Contact VINCENT LEE
Correspondent
VATECH Co., Ltd.
256 N. Sam Houston Pkwy. E.
Suite 115
Houston,  TX  77060
Correspondent Contact VINCENT LEE
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/14/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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