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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 K130602
Device Name LASSO NAV DUO LOOP CATHETER
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD
DIAMOND BAR,  CA  91765
Applicant Contact JOHN JIMENEZ
Correspondent
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD
DIAMOND BAR,  CA  91765
Correspondent Contact JOHN JIMENEZ
Regulation Number870.1220
Classification Product Code
DRF  
Date Received03/07/2013
Decision Date 08/14/2013
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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