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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 K861369
Device Name INCUS/STAPES PROSTHESIS
Applicant
RICHARDS MEDICAL CO., INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact ROBERTS F GAMES
Correspondent
RICHARDS MEDICAL CO., INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact ROBERTS F GAMES
Regulation Number874.3450
Classification Product Code
ETB  
Date Received04/11/1986
Decision Date 07/14/1986
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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