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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name perimeter, ac-powered
510(k) Number K832800
Device Name AUTOMATIC TANGENT SCREEN 50
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 Number886.1605
Classification Product Code
HOO  
Date Received08/18/1983
Decision Date 09/29/1983
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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