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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 K972734
Device Name PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
Applicant
MEDNET LOCATOR, INC.
7000 SHADOW OAKS
MEMPHIS,  TN  38125
Applicant Contact JUDY S CHANDLER
Correspondent
MEDNET LOCATOR, INC.
7000 SHADOW OAKS
MEMPHIS,  TN  38125
Correspondent Contact JUDY S CHANDLER
Regulation Number874.3450
Classification Product Code
ETB  
Date Received07/22/1997
Decision Date 09/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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