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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 K082781
Device Name OEC 9900 ELITE
Applicant
Ge Healthcare Surgery
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact MARIA C FRAME
Correspondent
Ge Healthcare Surgery
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 Received09/22/2008
Decision Date 05/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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