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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 K950927
Device Name HAPEX MALLEABLE TORP
Applicant
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact DEBORAH A ARTHUR
Correspondent
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact DEBORAH A ARTHUR
Regulation Number874.3495
Classification Product Code
ETA  
Date Received03/01/1995
Decision Date 03/21/1995
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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