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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K960265
Device Name ADVANTAGE WINDOWS WITH FUNCTOOL OPTION
Applicant
GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/18/1996
Decision Date 07/03/1996
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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