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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K941920
Device Name INTERACOUSTICS CLINICAL AUDIOMETER
Applicant
Precision Acoustics Ind., Inc.
501 Fifth Ave.
New York,  NY  10017
Applicant Contact MICHAEL DAVIS
Correspondent
Precision Acoustics Ind., Inc.
501 Fifth Ave.
New York,  NY  10017
Correspondent Contact MICHAEL DAVIS
Regulation Number874.1050
Classification Product Code
EWO  
Date Received04/20/1994
Decision Date 09/16/1994
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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