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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 K992466
Device Name OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
Applicant
Ocu-Ease Optical Products, Inc.
629 Tennent Ave.
Pinole,  CA  94564
Applicant Contact CHARLES R VERMETTE
Correspondent
Ocu-Ease Optical Products, Inc.
629 Tennent Ave.
Pinole,  CA  94564
Correspondent Contact CHARLES R VERMETTE
Regulation Number886.5925
Classification Product Code
LPL  
Date Received07/23/1999
Decision Date 10/04/1999
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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