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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Reading, Television, Closed-Circuit
510(k) Number K892350
Device Name MAGNILINK SYSTEM 402/5
Applicant
Coburn Optical Ind., Inc.
4606 S. Garnett Rd.
Suite 200
Tulsa,  OK  74146
Applicant Contact DE LONG
Correspondent
Coburn Optical Ind., Inc.
4606 S. Garnett Rd.
Suite 200
Tulsa,  OK  74146
Correspondent Contact DE LONG
Regulation Number886.5820
Classification Product Code
HJG  
Date Received04/05/1989
Decision Date 05/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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