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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 K250256
Device Name Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
Applicant
Aventamed Dac
Rubicon Centre
Rossa Ave.
Bishopstown,  IE T12 Y275
Applicant Contact Keith Jansen
Correspondent
Aventamed Dac
Rubicon Centre
Rossa Ave.
Bishopstown,  IE T12 Y275
Correspondent Contact Keith Jansen
Regulation Number874.3880
Classification Product Code
ETD  
Date Received01/28/2025
Decision Date 04/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT05741333
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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