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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 K881971
Device Name OCCU-TECH VISION TEST
Applicant
Applied Vision Concepts, Inc.
9898 SW Lynnwood Terr.
Portland,  OR  97225
Applicant Contact SALIBELLO, OD
Correspondent
Applied Vision Concepts, Inc.
9898 SW Lynnwood Terr.
Portland,  OR  97225
Correspondent Contact SALIBELLO, OD
Regulation Number886.1150
Classification Product Code
HOX  
Date Received05/11/1988
Decision Date 11/25/1988
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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