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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 K001142
Device Name AUDIO TECHNOLOGIES S:R.1
Applicant
AUDIO TECHNOLOGIES S.R.L.
VIA DELL'ARTIGINATO, 8
GOSSOLENGO
PIACENZA,  IT 29020
Applicant Contact FRANCO BEONI
Correspondent
AUDIO TECHNOLOGIES S.R.L.
VIA DELL'ARTIGINATO, 8
GOSSOLENGO
PIACENZA,  IT 29020
Correspondent Contact FRANCO BEONI
Regulation Number874.3450
Classification Product Code
ETB  
Subsequent Product Code
ETA  
Date Received04/10/2000
Decision Date 06/23/2000
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
Predetermined Change
Control Plan Authorized		 No
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