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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 K080179
Device Name REFLEXION HD HIGH-DENSITY MAPPING CATHETER
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Applicant Contact ANDREA HUDACK
Correspondent
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Correspondent Contact ANDREA HUDACK
Regulation Number870.1220
Classification Product Code
DRF  
Date Received01/24/2008
Decision Date 01/07/2009
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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