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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name table, radiographic, tilting
510(k) Number K954356
Device Name COMPAX 90/15E
Original Applicant
GENERAL ELECTRIC CO.
p0 box 414
milwaukee,  WI 
Original Contact larry a kroher
Regulation Number892.1980
Classification Product Code
IXR  
Date Received09/18/1995
Decision Date 10/07/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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