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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 K941607
Device Name UCL MULTIFOCAL SOFT CONTACT LENS
Applicant
United Contact Lens, Inc.
3717 - 196th St. SW
Suite 215
Lynnwoodo,  WA  98036
Applicant Contact DONALD T COOK
Correspondent
United Contact Lens, Inc.
3717 - 196th St. SW
Suite 215
Lynnwoodo,  WA  98036
Correspondent Contact DONALD T COOK
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/31/1994
Decision Date 06/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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