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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 K964909
Device Name ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
Applicant
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact DAVID TIMLIN
Correspondent
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact DAVID TIMLIN
Regulation Number874.3450
Classification Product Code
ETB  
Subsequent Product Code
ETA  
Date Received12/09/1996
Decision Date 03/10/1997
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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