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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 K002976
Device Name RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
Applicant
St Jude Medical
14901 De Veau Place
Minnetonka,  MN  55345
Applicant Contact DEAN BRUHN-DING
Correspondent
St Jude Medical
14901 De Veau Place
Minnetonka,  MN  55345
Correspondent Contact DEAN BRUHN-DING
Regulation Number870.1220
Classification Product Code
DRF  
Date Received09/25/2000
Decision Date 12/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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