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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 K954524
Device Name W-55 (METHAFILON A) CONTACT LENS
Applicant
Westcon Contact Lens Co., Inc.
611 Eisenhauer St.
Grnad Junction,  CO  81505
Applicant Contact MARTIN DALSING
Correspondent
Westcon Contact Lens Co., Inc.
611 Eisenhauer St.
Grnad Junction,  CO  81505
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/29/1995
Decision Date 03/28/1996
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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