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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 K073696
Device Name VERAVIEWEPOCS
Applicant
J. Morita USA, Inc.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
J. Morita USA, Inc.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Correspondent Contact KEITH A BARRITT
Regulation Number872.1800
Classification Product Code
MUH  
Date Received12/31/2007
Decision Date 04/08/2008
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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