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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 K100317
Device Name DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
Applicant
VATECH Co., Ltd.
256 N. Sam Houston Pkwy. E.
# 115
Houston,  TX  77060
Applicant Contact DAVE KIM
Correspondent
VATECH Co., Ltd.
256 N. Sam Houston Pkwy. E.
# 115
Houston,  TX  77060
Correspondent Contact DAVE KIM
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Codes
EHD   MQB  
Date Received02/04/2010
Decision Date 03/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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