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510(k) K802870

Device
RION ELECTRO-PALATOGRAPH MODEL DP-01
Applicant
KINDEL & ANDERSON
510(k) number
K802870
Product code
LEZ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-12-17
Date received
1980-11-14
Regulation
510(k) Premarket Notification
Classification name
Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact)
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Ear Nose & Throat
Device class
U
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LEZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091682LSVT C OR LSVT COMPANION, MODEL V.1Lsvt Global, LLC2009-08-20
K982396VISIVOX, MODEL V-2Rsq, LLC1998-09-14

Legacy Summary#

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FDA Review#

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