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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 K913286
Device Name H/A TOTAL-REGULAR, H/A TOTAL-OFFSET
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 Number874.3495
Classification Product Code
ETA  
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
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