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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 K003789
FOIA Releasable 510(k) K003789
Device Name SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT
Applicant
Specialty Ultravision, Inc.
307 Orchard City Dr.
Suite 100
Campbell,  CA  95008
Applicant Contact DEBBIE MCINTIRE
Correspondent
Specialty Ultravision, Inc.
307 Orchard City Dr.
Suite 100
Campbell,  CA  95008
Correspondent Contact DEBBIE MCINTIRE
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/08/2000
Decision Date 02/21/2001
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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