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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 K111551
Device Name OEC(R) 9800, OEC(R) 9800 PLUS
Applicant
GE OEC MEDICAL SYSTEMS, INC
384 WRIGHT BROTHERS DR.
salt lake city,  UT  84116
Applicant Contact gerald buss
Correspondent
GE OEC MEDICAL SYSTEMS, INC
384 WRIGHT BROTHERS DR.
salt lake city,  UT  84116
Correspondent Contact gerald buss
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received06/03/2011
Decision Date 10/04/2011
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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