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510(k) K892347

Device
MAGNILINK SYSTEM 101
Applicant
COBURN OPTICAL IND., INC.
510(k) number
K892347
Product code
HJG  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-26
Date received
1989-04-05
Regulation
886.5820
Classification name
System, Reading, Television, Closed-circuit
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DE LONG
Address
4606 S. Garnett Rd. Suite 200 Tulsa OK US 74146 74146

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HJG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933633LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATEGracefully Yours, Inc.1994-02-22
K915340MENTOR HORIZON LOW VISION MAGNIFIERMentor O & O, Inc.1992-03-30
K920069MAGNI-CAMInnoventions, Inc.1992-03-02
K892348MAGNILINK SYSTEM 201Coburn Optical Ind., Inc.1989-05-26
K892349MAGNILINK SYSTEM 209Coburn Optical Ind., Inc.1989-05-26
K892350MAGNILINK SYSTEM 402/5Coburn Optical Ind., Inc.1989-05-26
K892351MAGNILINK SYSTEM 602Coburn Optical Ind., Inc.1989-05-26

Legacy Summary#

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FDA Review#

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