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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name eustachian tube balloon dilation device
510(k) Number K171761
Device Name ACCLARENT AERA Eustachian Tube Balloon Dilation System
Applicant
Acclarent, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact James Patrick Garvey II
Correspondent
Acclarent, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact James Patrick Garvey II
Regulation Number874.4180
Classification Product Code
PNZ  
Date Received06/14/2017
Decision Date 01/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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