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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 K082875
Device Name PORTABLE X-RAY SYSTEM, MODEL DXR -1
Applicant
Exaro Co., Ltd.
215 S. State St. # 100b
Salt Lake City,  UT  84111
Applicant Contact SHIN KUK YOO
Correspondent
Exaro Co., Ltd.
215 S. State St. # 100b
Salt Lake City,  UT  84111
Correspondent Contact SHIN KUK YOO
Regulation Number872.1800
Classification Product Code
EHD  
Subsequent Product Code
MUH  
Date Received09/29/2008
Decision Date 02/05/2009
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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