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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tester, auditory impedance
510(k) Number K974235
Device Name AMPLAID AM50
Applicant
AMPLIFON S.P.A.
P.O. BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
AMPLIFON S.P.A.
P.O. BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number874.1090
Classification Product Code
ETY  
Date Received11/12/1997
Decision Date 02/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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