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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K161701
Device Name CARTO ENT System
Applicant
Biosense Webster
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Applicant Contact MELISSA C. SCHULTZ
Correspondent
Biosense Webster
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Correspondent Contact MELISSA C. SCHULTZ
Regulation Number882.4560
Classification Product Code
PGW  
Date Received06/20/2016
Decision Date 10/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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