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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 K033211
Device Name ENSITE SYSTEM
Applicant
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Applicant Contact KAREN J MCKELVEY
Correspondent
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Correspondent Contact KAREN J MCKELVEY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/03/2003
Decision Date 10/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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