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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K033050
Device Name EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
Applicant
Medtronic Vascular
7000 Central Ave. NE
Minneapolis,  MN  55432 -3576
Applicant Contact MAC MCKEEN
Correspondent
Medtronic Vascular
7000 Central Ave. NE
Minneapolis,  MN  55432 -3576
Correspondent Contact MAC MCKEEN
Regulation Number870.1220
Classification Product Code
DRF  
Date Received09/29/2003
Decision Date 03/26/2004
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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