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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tympanostomy
510(k) Number K232702
Device Name Solo+ Tympanostomy Tube Device (TTD)
Applicant
AventaMed DAC
Rubicon Centre, Rossa Avenue,
Bishopstown,  IE T12 Y275
Applicant Contact Keith Jansen
Correspondent
AventaMed DAC
Rubicon Centre, Rossa Avenue,
Bishopstown,  IE T12 Y275
Correspondent Contact Keith Jansen
Regulation Number874.3880
Classification Product Code
ETD  
Date Received09/05/2023
Decision Date 05/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT04148417
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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