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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K931049
Device Name ADVANTX SYSTEM
Applicant
GE Medical Systems
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
GE Medical Systems
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact LARRY A KROGER
Regulation Number892.1700
Classification Product Code
IZO  
Date Received03/01/1993
Decision Date 05/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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