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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 K023178
Device Name INNOVA 4100
Applicant
GE MEDICAL SYSTEMS, INC.
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER, PH.D
Correspondent
GE MEDICAL SYSTEMS, INC.
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact LARRY A KROGER, PH.D
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received09/23/2002
Decision Date 11/26/2002
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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