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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
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