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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K924991
Device Name MICRO MASKER
Applicant
ASSOCIATED HEARING INSTRUMENTS
6796 MARKET ST.
UPPER DARBY,  PA  19082
Applicant Contact ROBERT LIBBY
Correspondent
ASSOCIATED HEARING INSTRUMENTS
6796 MARKET ST.
UPPER DARBY,  PA  19082
Correspondent Contact ROBERT LIBBY
Regulation Number874.3400
Classification Product Code
KLW  
Date Received10/01/1992
Decision Date 06/14/1993
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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