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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 K913285
Device Name PTFE PISTON
Applicant
River Medical, Inc.
P.O.Box 30517
Memphis,  TN  38130
Applicant Contact GEORGE W MURRAY
Correspondent
River Medical, Inc.
P.O.Box 30517
Memphis,  TN  38130
Correspondent Contact GEORGE W MURRAY
Regulation Number874.3450
Classification Product Code
ETB  
Date Received07/24/1991
Decision Date 12/18/1991
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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