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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 K031477
Device Name HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS
Applicant
Ocular Sciences, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Applicant Contact RICHARD E LIPPMAN
Correspondent
Ocular Sciences, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received05/09/2003
Decision Date 07/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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