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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 K230742
Device Name ACCLARENT AERA Eustachian Tube Dilation System
Applicant
Acclarent, Inc.
31 Technology Dr.
Irvine,  CA  92618
Applicant Contact Kamrie Sarnosky
Correspondent
Acclarent, Inc.
31 Technology Dr.
Irvine,  CA  92618
Correspondent Contact Kamrie Sarnosky
Regulation Number874.4180
Classification Product Code
PNZ  
Date Received03/17/2023
Decision Date 12/13/2023
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
Predetermined Change
Control Plan Authorized		 No
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