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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 K022069
Device Name OEC FLUOROTRAK 9800 PLUS
Applicant
GE OEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Applicant Contact BILL GISLASON
Correspondent
GE OEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact BILL GISLASON
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received06/25/2002
Decision Date 09/17/2002
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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