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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 K193453
Device Name TruDi Probe
Applicant
Acclarent, Inc.
31 Technology Drive
Irvine,  CA  92618
Applicant Contact Leena Sorathia
Correspondent
Acclarent, Inc.
31 Technology Drive
Irvine,  CA  92618
Correspondent Contact Leena Sorathia
Regulation Number882.4560
Classification Product Code
PGW  
Date Received12/13/2019
Decision Date 03/23/2020
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
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