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510(k) K990240

Device
ELECTROGLOTTOGRAPH
Applicant
KAY ELEMETRICS CORP.
510(k) number
K990240
Product code
KLX  
Decision
Substantially Equivalent (SESE)
Decision date
1999-03-11
Date received
1999-01-25
Regulation
874.1325
Classification name
Electroglottograph
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM D HARBESON
Address
2 Bridgewater Ln. Lincoln Park NJ US 07035 07035

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KLX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K901609ELECTROGLOTTOGRAPHGlottal Ent., Inc.1990-06-28
K841832GLOTTAL FREQUENCY ANALYSERTeltec Electronic Equipment AB1984-07-18
K821079ELECTROGLOTTOGRAPH NAKED EGG BOXED EGGMs. Kate Teaney1982-05-10

Legacy Summary#

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FDA Review#

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