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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, ent manual surgical
510(k) Number K190525
Device Name RELIEVA ULTIRRA Sinus Balloon Catheter
Acclarent, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact Leena Sorathia
Acclarent, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact Leena Sorathia
Regulation Number874.4420
Classification Product Code
Date Received03/04/2019
Decision Date 05/03/2019
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