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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chart, Visual Acuity
510(k) Number K883337
Device Name PL 20/20 INFANT VISION TESTER
Applicant
Optimed Technologies, Inc.
515 E. 22nd Ter.
P.O. Box 3663
Lawrence,  KS  66046
Applicant Contact BONNIE L MINKIN,PHD
Correspondent
Optimed Technologies, Inc.
515 E. 22nd Ter.
P.O. Box 3663
Lawrence,  KS  66046
Correspondent Contact BONNIE L MINKIN,PHD
Regulation Number886.1150
Classification Product Code
HOX  
Date Received08/09/1988
Decision Date 10/31/1988
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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