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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 K052560
Device Name BIOFINITY (COMFILCON A) SOFT CONTACT LENS
Applicant
COOPERVISION, INC.
5870 STONERIDGE DR.
SUITE 1
PLEASANTON,  CA  94588
Applicant Contact JACK P DOUGLAS
Correspondent
COOPERVISION, INC.
5870 STONERIDGE DR.
SUITE 1
PLEASANTON,  CA  94588
Correspondent Contact JACK P DOUGLAS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/16/2005
Decision Date 12/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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