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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intracardiac mapping, high-density array
510(k) Number K130827
Device Name FIRMAP CATHETER
Applicant
TOPERA, INC.
3668 S. GEYER ROAD
SUITE 365
ST. LOUIS,  MO  63127
Applicant Contact MELISSA WALKER
Correspondent
TOPERA, INC.
3668 S. GEYER ROAD
SUITE 365
ST. LOUIS,  MO  63127
Correspondent Contact MELISSA WALKER
Regulation Number870.1220
Classification Product Code
MTD  
Date Received03/26/2013
Decision Date 10/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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