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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 K840255
Device Name VISTECH VCTS 6000
Applicant
VISTECH CONSULTANTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VISTECH CONSULTANTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.1150
Classification Product Code
HOX  
Date Received01/23/1984
Decision Date 04/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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