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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, pulsed doppler, ultrasonic
510(k) Number K001267
Device Name GE SYSTEM FIVE
Applicant
GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact ALLEN SCHUH
Correspondent
GE MEDICAL SYSTEMS, INC.
P.O. BOX 7550
MADISON,  WI  53707
Correspondent Contact Monica Morrison
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/20/2000
Decision Date 05/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
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