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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 K201115
Device Name Next Generation Balloon Dilation System
Applicant
Acclarent Inc.
31 Technology Dr., Suite 200
Irvine,  CA  92618
Applicant Contact David Locke
Correspondent
Acclarent Inc.
31 Technology Dr., Suite 200
Irvine,  CA  92618
Correspondent Contact David Locke
Regulation Number874.4420
Classification Product Code
LRC  
Subsequent Product Codes
PGW   PNZ  
Date Received04/27/2020
Decision Date 08/27/2020
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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