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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 K962710
Device Name GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
Applicant
Gelflex Laboratories
3 Hutton St., Osborne Park
Perth, Western, Wa,  AU 6017
Applicant Contact PETER G BRYANT
Correspondent
Gelflex Laboratories
3 Hutton St., Osborne Park
Perth, Western, Wa,  AU 6017
Correspondent Contact PETER G BRYANT
Regulation Number886.5925
Classification Product Code
LPL  
Date Received06/10/1996
Decision Date 09/05/1996
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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