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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 K113213
Device Name LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
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 Received11/01/2011
Decision Date 12/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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