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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 K862471
Device Name WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER
Applicant
INSTITUTE OF LOGOPEDICS
C/O MEDICAL DEVICE CONSULTANTS
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact WILLIAM MORTON
Correspondent
INSTITUTE OF LOGOPEDICS
C/O MEDICAL DEVICE CONSULTANTS
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Correspondent Contact WILLIAM MORTON
Classification Product Code
LRA  
Date Received06/30/1986
Decision Date 09/12/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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