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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 K823910
Device Name DONALDSON VENT TUBE
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 Number874.3880
Classification Product Code
ETD  
Date Received12/28/1982
Decision Date 11/22/1983
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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