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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
510(k) Number K982396
Device Name VISIVOX, MODEL V-2
Applicant
RSQ, LLC.
636 WELLESLEY DR.
CLAREMONT,  CA  91711 -3427
Applicant Contact DORIS DRUCKER
Correspondent
RSQ, LLC.
636 WELLESLEY DR.
CLAREMONT,  CA  91711 -3427
Correspondent Contact DORIS DRUCKER
Classification Product Code
LEZ  
Date Received07/09/1998
Decision Date 09/14/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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