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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name inserter, myringotomy tube
510(k) Number K822348
Device Name TYTAN TUBE INSERTER
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 Number874.4420
Classification Product Code
JYM  
Date Received08/06/1982
Decision Date 09/07/1982
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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