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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Partial Ossicular Replacement
510(k) Number K823439
Device Name CAUSSE TEF-PISTON
Applicant
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number874.3450
Classification Product Code
ETB  
Date Received11/16/1982
Decision Date 12/03/1982
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
Predetermined Change
Control Plan Authorized		 No
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