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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 K000376
Device Name SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT
Applicant
SPECIALTY ULTRAVISION, INC.
307 ORCHARD CITY DR.
CAMPBELL,  CA  95008
Applicant Contact GAROLD L EDWARDS
Correspondent
SPECIALTY ULTRAVISION, INC.
307 ORCHARD CITY DR.
CAMPBELL,  CA  95008
Correspondent Contact GAROLD L EDWARDS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/07/2000
Decision Date 03/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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