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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 K053435
Device Name GE VOLUSON I
Applicant
GENERAL ELECTRIC CO.
4855 WEST ELECTRIC AVENUE
PO BOX 414
MILWAUKEE,  WI  53201
Applicant Contact ALLEN SMITH
Correspondent
GENERAL ELECTRIC CO.
4855 WEST ELECTRIC AVENUE
PO BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact ALLEN SMITH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/09/2005
Decision Date 12/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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