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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, Fluoroscopic, Image-Intensified
510(k) Number K943805
Device Name PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
Applicant
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact LARRY A KROGER
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/04/1994
Decision Date 09/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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