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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 K881023
Device Name VCTS 6500 SYSTEM
Applicant
Vistech Consultants, Inc.
1372 Noth Fairfield Rd.
Dayton,  OH  45432
Applicant Contact DENNIS J MCCREIGHT
Correspondent
Vistech Consultants, Inc.
1372 Noth Fairfield Rd.
Dayton,  OH  45432
Correspondent Contact DENNIS J MCCREIGHT
Regulation Number886.1150
Classification Product Code
HOX  
Date Received03/10/1988
Decision Date 04/01/1988
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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