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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
Original Applicant
GE OEC MEDICAL SYSTEMS, INC.
384 wright brothers dr.
salt lake city,  UT  84116
Original 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 (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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