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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name porous polyethylene ossicular replacement
510(k) Number K823442
Device Name FISCH MODIFIED TOTAL OSSICULAR PROSTHES
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
LBM  
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
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