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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intracardiac Mapping, High-Density Array
510(k) Number K012926
Device Name MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
Applicant
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Applicant Contact ERIC W KOEHLER
Correspondent
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Correspondent Contact ERIC W KOEHLER
Regulation Number870.1220
Classification Product Code
MTD  
Date Received08/31/2001
Decision Date 09/28/2001
Decision SE - With Limitations (SESU)
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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