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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 K950886
Device Name HAPEX PORP
Applicant
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact RONALD K SMITH
Correspondent
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact RONALD K SMITH
Regulation Number874.3450
Classification Product Code
ETB  
Date Received02/28/1995
Decision Date 03/15/1995
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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