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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 K993580
Device Name SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
Applicant
SPECIALTY ULTRAVISION, INC.
307 ORCHARD CITY DR.
SUITE 100
CAMPBELL,  CA  95008
Applicant Contact RICHARD LIPPMAN
Correspondent
SPECIALTY ULTRAVISION, INC.
307 ORCHARD CITY DR.
SUITE 100
CAMPBELL,  CA  95008
Correspondent Contact RICHARD LIPPMAN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received10/22/1999
Decision Date 02/02/2000
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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