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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 K040900
Device Name S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant
Optical Connection, Inc.
2091 Upper Scenic Dr.
Felton,  CA  95018
Applicant Contact GAROLD L EDWARDS
Correspondent
Optical Connection, Inc.
2091 Upper Scenic Dr.
Felton,  CA  95018
Correspondent Contact GAROLD L EDWARDS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/06/2004
Decision Date 06/15/2004
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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