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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 K010126
Device Name PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
Applicant
Cl-Tinters
10 Warrenton Ln.
Colts Neck,  NJ  07722
Applicant Contact MARTIN S KNOPF
Correspondent
Cl-Tinters
10 Warrenton Ln.
Colts Neck,  NJ  07722
Correspondent Contact MARTIN S KNOPF
Regulation Number886.5925
Classification Product Code
LPL  
Date Received01/16/2001
Decision Date 03/12/2001
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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