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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, Extraoral Source, Digital
510(k) Number K113672
Device Name PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
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 Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
MQB  
Date Received12/13/2011
Decision Date 03/27/2012
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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