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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 K040303
Device Name 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
Applicant
Hydrogel Vision Corporation
6447 Parkland Dr.
Sarasota,  FL  34243
Applicant Contact DONNA HOVANEC
Correspondent
Hydrogel Vision Corporation
6447 Parkland Dr.
Sarasota,  FL  34243
Correspondent Contact DONNA HOVANEC
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/09/2004
Decision Date 02/02/2005
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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