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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 K171687
Device Name Relieva SpinPlus Nav Balloon Sinuplasty 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 Number874.4420
Classification Product Code
LRC  
Subsequent Product Code
PGW  
Date Received06/07/2017
Decision Date 09/05/2017
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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