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510(k) K897143

Device
VERA 103
Applicant
MADSEN NORTH AMERICA, INC.
510(k) number
K897143
Product code
LYN  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-27
Date received
1989-12-27
Regulation
874.1050
Classification name
Apparatus, Visual Reinforcement Audiometric
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ZOILA SEERY
Address
908 Niagara Falls Blvd. North Tonawanda NY US 14120 14120

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950995SENSICARE SYNTHETIC, SURGICAL GLOVE LINERBd Becton Dickinson Vacutainer Systems Preanalytic1995-06-28
K880259VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADVColorado Hearing Systems, Inc.1989-04-03

Legacy Summary#

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FDA Review#

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