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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K992948
Device Name MAC-LAB SYSTEM
Applicant
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact MARIA VITUG FOUTS
Correspondent
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact MARIA VITUG FOUTS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/31/1999
Decision Date 11/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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