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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K991014
Device Name CASE 8000 EXERCISE TESTING SYSTEM
Applicant
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact LAURA L MCCOMIS
Correspondent
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact LAURA L MCCOMIS
Classification Product Code
LOS
Date Received03/26/1999
Decision Date 10/20/1999
Decision Substantially Equivalent (SESE)
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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