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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 K962564
Device Name RICHARDS TOTAL/PARTIAL PROSTHESIS
Applicant
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Applicant Contact RONALD K SMITH
Correspondent
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact RONALD K SMITH
Regulation Number874.3450
Classification Product Code
ETB  
Subsequent Product Code
ETA  
Date Received07/01/1996
Decision Date 01/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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