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510(k) K800445

Device
EDINBURGH MASKER
Applicant
FOUNDATION FOR FLUENCY, INC.
510(k) number
K800445
Product code
KTH  
Decision
Substantially Equivalent (SESE)
Decision date
1980-03-12
Date received
1980-02-28
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K871590VOCALTECH VOCAL FEEDBACK DEVICEVocaltech C/O Hogan & Hartson1987-10-06

Legacy Summary#

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FDA Review#

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