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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 K013955
Device Name VERAVIEWEPOCS, MODEL VE
Applicant
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Applicant Contact WILLIAM D HARE
Correspondent
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Correspondent Contact WILLIAM D HARE
Regulation Number872.1800
Classification Product Code
EHD  
Date Received11/30/2001
Decision Date 02/04/2002
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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