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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K040165
Device Name REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
Applicant
St Jude Medical
14901 De Veau Place
Minnetonka,  MN  55345
Applicant Contact GLENN JACQUES
Correspondent
St Jude Medical
14901 De Veau Place
Minnetonka,  MN  55345
Correspondent Contact GLENN JACQUES
Regulation Number870.1280
Classification Product Code
DRA  
Date Received01/26/2004
Decision Date 05/12/2004
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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