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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K253580
Device Name Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
Applicant
Tedan Surgical Innovations
12320 Cardinal Meadow Dr.
Suite 150
Sugar Land,  TX  77478
Applicant Contact Arya Monticino-Larsen
Correspondent
Tedan Surgical Innovations
12320 Cardinal Meadow Dr.
Suite 150
Sugar Land,  TX  77478
Correspondent Contact Arya Monticino-Larsen
Regulation Number874.1820
Classification Product Code
PDQ  
Date Received11/17/2025
Decision Date 04/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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