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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 K173628
Device Name Acclarent ENT Navigation System
Applicant
Acclarent, Inc.
1525-B O’Brien Dr.
Menlo Park,  CA  94025
Applicant Contact James Patrick Garvey
Correspondent
Acclarent, Inc.
1525-B O’Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact James Patrick Garvey
Regulation Number882.4560
Classification Product Code
PGW  
Date Received11/24/2017
Decision Date 03/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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