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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 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact WILLIAM MORTON
Correspondent
Institute of Logopedics
C/O Medical Device Consultants
45 W. St., 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
Predetermined Change
Control Plan Authorized		 No
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