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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 K132027
Device Name OEC 9800 PLUS
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 Received07/01/2013
Decision Date 05/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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