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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 K830011
Device Name VFS 1000/SCREENING FUNCTION ANALYZER
Applicant
COOPERVISION, INC.
PERMALENS HOUSE
1 BOTLEY ROAD, HEDGE END
SOUTHAMPTON,  GB S033HB
Correspondent
COOPERVISION, INC.
PERMALENS HOUSE
1 BOTLEY ROAD, HEDGE END
SOUTHAMPTON,  GB S033HB
Regulation Number886.1150
Classification Product Code
HOX  
Date Received01/03/1983
Decision Date 01/17/1983
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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