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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 K081664
Device Name NOMAD PRO X-RAY SYSTEM
Applicant
ARIBEX, INC.
744 SOUTH 400 EAST
OREM,  UT  84651
Applicant Contact D. CLARK TURNER
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received06/13/2008
Decision Date 06/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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