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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 K043076
Device Name GE OEC FLUOROSTAR
Applicant
GE OEC MEDICAL SYSTEMS, INC.
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Applicant Contact JEFF WAGNER
Correspondent
GE OEC MEDICAL SYSTEMS, INC.
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact JEFF WAGNER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received11/08/2004
Decision Date 12/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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