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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, Tactile
510(k) Number K851655
Device Name TEACHER TM
Applicant
Monargue Intl.
21757 Devonshire St.,
Suite 12a
Chatsworth,  CA  91311
Applicant Contact JOHN A ANDROSS
Correspondent
Monargue Intl.
21757 Devonshire St.,
Suite 12a
Chatsworth,  CA  91311
Correspondent Contact JOHN A ANDROSS
Classification Product Code
LRA  
Date Received04/22/1985
Decision Date 06/20/1985
Decision Substantially Equivalent (SESE)
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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