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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 K974077
Device Name VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.
Applicant
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received10/29/1997
Decision Date 01/20/1998
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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