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510(k) K962961

Device
SUSTAINED PHONATION
Applicant
SURFACE MOUNT TECHNOLOGY, INC.
510(k) number
K962961
Product code
KTH  
Decision
Substantially Equivalent (SESE)
Decision date
1996-09-09
Date received
1996-07-30
Regulation
874.5840
Classification name
Device, Anti-stammering
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROGER ZIMMERMAN
Address
2181 Pinnacle Pkwy. Twinsburg OH US 44087 44087

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
K942651BIOFEEDBACK SYSTEM FOR SPEECH DISORDERSCasa Futura Technologies1995-10-19
K871590VOCALTECH VOCAL FEEDBACK DEVICEVocaltech C/O Hogan & Hartson1987-10-06
K800445EDINBURGH MASKERFoundation For Fluency, Inc.1980-03-12

Legacy Summary#

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FDA Review#

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