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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 K992010
Device Name W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)
Applicant
Westcon Contact Lens Co., Inc.
611 Eisenhauer St.
Grnad Junction,  CO  81505
Applicant Contact CAROL NOBLE
Correspondent
Westcon Contact Lens Co., Inc.
611 Eisenhauer St.
Grnad Junction,  CO  81505
Correspondent Contact CAROL NOBLE
Regulation Number886.5925
Classification Product Code
LPL  
Date Received06/15/1999
Decision Date 06/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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