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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon, Nasal Airway
510(k) Number K183090
Device Name Relieva Tract Balloon Dilation System
Applicant
Acclarent, Inc.
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Leena Sorathia
Correspondent
Acclarent, Inc.
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Leena Sorathia
Regulation Number874.4420
Classification Product Code
QGK  
Date Received11/06/2018
Decision Date 04/19/2019
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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