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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, X-Ray, Electrostatic
510(k) Number K032654
Device Name PORT CASSETTE
Applicant
Orex Computed Radiography, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Orex Computed Radiography, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number892.1630
Classification Product Code
IXK  
Date Received08/28/2003
Decision Date 10/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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