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510(k) K871590

Device
VOCALTECH VOCAL FEEDBACK DEVICE
Applicant
VOCALTECH C/O HOGAN & HARTSON
510(k) number
K871590
Product code
KTH  
Decision
Substantially Equivalent (SESE)
Decision date
1987-10-06
Date received
1987-04-24
Regulation
874.5840
Classification name
Device, Anti-stammering
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JONATHAN S KAHAN
Address
Columbia Sq. 555 Thirteenth St., NW Washington, D.C. DC US 20004 20004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KTH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962961SUSTAINED PHONATIONSurface Mount Technology, Inc.1996-09-09
K942651BIOFEEDBACK SYSTEM FOR SPEECH DISORDERSCasa Futura Technologies1995-10-19
K800445EDINBURGH MASKERFoundation For Fluency, Inc.1980-03-12

Legacy Summary#

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FDA Review#

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