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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 K192397
Device Name TruDi Navigation System
Applicant
Biosense Webster
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact David Locke
Correspondent
Acclarent, Inc.
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact David Locke
Regulation Number882.4560
Classification Product Code
PGW  
Date Received09/03/2019
Decision Date 01/30/2020
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
Recalls CDRH Recalls
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