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510(k) K880259

Device
VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV
Applicant
COLORADO HEARING SYSTEMS, INC.
510(k) number
K880259
Product code
LYN  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-03
Date received
1988-01-22
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
ARLAN D ROGERS/CR
Address
P.O. Box 20324 Denver CO US 80220 80220

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
K897143VERA 103Madsen North America, Inc.1990-04-27

Legacy Summary#

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FDA Review#

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