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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lenses, soft contact, daily wear
510(k) Number K962185
Device Name HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
Applicant
COOPERVISION, INC.
200 WILLOWBROOK OFFICE PARK
FAIRPORT,  NY  14450 -0000
Applicant Contact BERNARD HALLATT
Correspondent
COOPERVISION, INC.
200 WILLOWBROOK OFFICE PARK
FAIRPORT,  NY  14450 -0000
Correspondent Contact BERNARD HALLATT
Regulation Number886.5925
Classification Product Code
LPL  
Date Received06/06/1996
Decision Date 12/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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