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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 K180948
Device Name TruDi NAV Suction Instruments
Applicant
Acclarent, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact Leena Sorathia
Correspondent
Acclarent, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact Leena Sorathia
Regulation Number882.4560
Classification Product Code
PGW  
Date Received04/11/2018
Decision Date 07/20/2018
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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