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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
Applicant
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA,  MN  55345 -2126
Applicant Contact MARLENE PETERSON
Correspondent
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA,  MN  55345 -2126
Correspondent 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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