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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 K252436
Device Name Tula Tympanostomy Tube Delivery Device
Applicant
Tusker Medical, Inc.
7000 W. William Cannon Dr., Suite.110
Austin,  TX  78735
Applicant Contact Nan McIntosh
Correspondent
Tusker Medical, Inc.
7000 W. William Cannon Dr., Suite.110
Austin,  TX  78735
Correspondent Contact Nan McIntosh
Regulation Number874.3880
Classification Product Code
ETD  
Date Received08/01/2025
Decision Date 04/23/2026
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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