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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, shunt, endolymphatic
510(k) Number K834094
Device Name AUSTIN ENDOLYMPH DISPERSMENT SHUNT
Applicant
TREACE MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TREACE MEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3820
Classification Product Code
ESZ  
Date Received11/28/1983
Decision Date 09/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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