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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K073543
Device Name OEC 9900 ELITE
Applicant
GE OEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Applicant Contact MARIA C FRAME
Correspondent
GE OEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact MARIA C FRAME
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received12/17/2007
Decision Date 05/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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