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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 Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Vocaltech C/O Hogan & Hartson
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  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
Predetermined Change
Control Plan Authorized		 No
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