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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name replacement, ossicular prosthesis, total
510(k) Number K864444
Device Name SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE
Applicant
RICHARDS MEDICAL CO., INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
RICHARDS MEDICAL CO., INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number874.3495
Classification Product Code
ETA  
Date Received11/12/1986
Decision Date 02/06/1987
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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