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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photostimulator, Ac-Powered
510(k) Number K914393
Device Name RETINA TESTER
Applicant
Retina Tester
3637 Park Ave.
Memphis,  TN  38111
Applicant Contact IRBY SEAY
Correspondent
Retina Tester
3637 Park Ave.
Memphis,  TN  38111
Correspondent Contact IRBY SEAY
Regulation Number886.1630
Classification Product Code
HLX  
Date Received10/01/1991
Decision Date 03/02/1992
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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