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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 K161698
Device Name Relieva UltirraNav Sinus Balloon Catheter
Applicant
ACCLARENT, INC.
33 TECHNOLOGY DRIVE
IRVINE,  CA  92618
Applicant Contact JAMES PATRICK GARVEY
Correspondent
ACCLARENT, INC.
33 TECHNOLOGY DRIVE
IRVINE,  CA  92618
Correspondent Contact JAMES PATRICK GARVEY
Regulation Number874.4420
Classification Product Code
LRC  
Date Received06/20/2016
Decision Date 10/24/2016
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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