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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 K120544
Device Name RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
Original Applicant
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka,  MN  55345 -2126
Original Contact marlene peterson
Regulation Number870.1220
Classification Product Code
DRF  
Date Received02/23/2012
Decision Date 03/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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