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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 K001404
Device Name GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
Applicant
MEDNET LOCATOR, INC.
7000 SHADOW OAKS
MEMPHIS,  TN  38125
Applicant Contact JUDY CHANDLER
Correspondent
MEDNET LOCATOR, INC.
7000 SHADOW OAKS
MEMPHIS,  TN  38125
Correspondent Contact JUDY CHANDLER
Regulation Number874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received05/03/2000
Decision Date 08/08/2000
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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