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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 K011072
Device Name GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS
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 Received04/09/2001
Decision Date 08/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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