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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 K113403
Device Name GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
Applicant
Ge Medical Systems Scs
283 Rue De La Miniere
Buc,  FR 78530
Applicant Contact MICHEL GENUER
Correspondent
Ge Medical Systems Scs
283 Rue De La Miniere
Buc,  FR 78530
Correspondent Contact MICHEL GENUER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received11/17/2011
Decision Date 02/14/2012
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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