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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 K230258
Device Name BB 8 Sinus Dilation Kit
Applicant
Excelent, Inc.
68 Tw Alexander Dr.
P.O. Box 13628, Research Triangle Park
Durham,  NC  27709
Applicant Contact Kashif Mazhar
Correspondent
Brosseau Consulting, LLC
2352 Kennesaw Oaks Trl. NW
Kennesaw,  GA  30152
Correspondent Contact Bryan Brosseau
Regulation Number874.4420
Classification Product Code
LRC  
Date Received01/31/2023
Decision Date 05/25/2023
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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