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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, catheter, punch
510(k) Number K771725
Device Name BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.
Applicant
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Correspondent
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Regulation Number876.5090
Classification Product Code
FEX  
Date Received09/13/1977
Decision Date 09/26/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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