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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 K952481
Device Name RICHARDS 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 Received05/30/1995
Decision Date 06/16/1995
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
Predetermined Change
Control Plan Authorized		 No
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