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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, angiographic
510(k) Number K111209
Device Name INTEGRATED INNOVA - S5I SYSTEM OPTION
Applicant
GE HEALTHCARE
283, RUE DE LA MINIERE
BUC,  FR 78530
Applicant Contact FAYCAL KHERRA
Correspondent
GE HEALTHCARE
283, RUE DE LA MINIERE
BUC,  FR 78530
Correspondent Contact FAYCAL KHERRA
Regulation Number892.1600
Classification Product Code
IZI  
Date Received04/29/2011
Decision Date 07/26/2011
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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