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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 K963764
Device Name SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR
Applicant
Specialty Ultravision, Inc.
6 Shadowbrook Dr.
Colts Neck,  NJ  07722
Applicant Contact MARTIN S KNOPF
Correspondent
Specialty Ultravision, Inc.
6 Shadowbrook Dr.
Colts Neck,  NJ  07722
Correspondent Contact MARTIN S KNOPF
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/19/1996
Decision Date 01/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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