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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K925103
Device Name AAHS HEARING AID
Applicant
AMERICAN HEARING SYSTEMS, INC.
6816 N.E. HWY 99
VANCOUVER,  WA  98665
Applicant Contact DAVID LASZLO
Correspondent
AMERICAN HEARING SYSTEMS, INC.
6816 N.E. HWY 99
VANCOUVER,  WA  98665
Correspondent Contact DAVID LASZLO
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/08/1992
Decision Date 11/06/1992
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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