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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 K024003
Device Name GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT
Applicant
Gelflex
Three Hutton St.
Osborne Park
Perth,  AU 6017
Applicant Contact PETER G BRYANT
Correspondent
Gelflex
Three Hutton St.
Osborne Park
Perth,  AU 6017
Correspondent Contact PETER G BRYANT
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/04/2002
Decision Date 02/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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