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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, tomography, computed
510(k) Number K982631
Device Name PHILIPS TOMOSCAN CS
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON,  CT  06484
Applicant Contact FRANK GIANELLI
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON,  CT  06484
Correspondent Contact FRANK GIANELLI
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/28/1998
Decision Date 10/06/1998
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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