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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 K923924
Device Name VOICEWAVE
Applicant
PERSONAL SOUND TECHNOLOGIES, INC.
400 ANDREWS ST.
SUITE 400
ROCHESTER,  NY  14604
Applicant Contact PAUL W O'BRIEN
Correspondent
PERSONAL SOUND TECHNOLOGIES, INC.
400 ANDREWS ST.
SUITE 400
ROCHESTER,  NY  14604
Correspondent Contact PAUL W O'BRIEN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/05/1992
Decision Date 08/24/1992
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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