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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 K984090
Device Name SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A)
Applicant
Specialty Ultravision, Inc.
307 Orchard City Dr.
Campbell,  CA  95008
Applicant Contact IVALEE I COHEN
Correspondent
Specialty Ultravision, Inc.
307 Orchard City Dr.
Campbell,  CA  95008
Correspondent Contact IVALEE I COHEN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received11/16/1998
Decision Date 07/07/1999
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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