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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 K051184
Device Name 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant
UNITED CONTACT LENS, INC.
2091 UPPER SCENIC DRIVE
FELTON,  CA  95018
Applicant Contact GAROLD L EDWARDS
Correspondent
UNITED CONTACT LENS, INC.
2091 UPPER SCENIC DRIVE
FELTON,  CA  95018
Correspondent Contact GAROLD L EDWARDS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/09/2005
Decision Date 07/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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