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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Stammering
510(k) Number K871590
Device Name VOCALTECH VOCAL FEEDBACK DEVICE
Applicant
VOCALTECH C/O HOGAN & HARTSON
COLUMBIA SQUARE
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
VOCALTECH C/O HOGAN & HARTSON
COLUMBIA SQUARE
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number874.5840
Classification Product Code
KTH  
Date Received04/24/1987
Decision Date 10/06/1987
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
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