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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, phacofragmentation
510(k) Number K833783
Device Name DISPOS. I/A & IRRIGATION HANDPIECES
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 Number886.4670
Classification Product Code
HQC  
Date Received10/28/1983
Decision Date 03/05/1984
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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