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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 K071736
Device Name AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
Applicant
COOPERVISION, INC.
6140 STONERIDGE MALL ROAD
SUITE 500
PLEASANTON,  CA  94588
Applicant Contact JACK P DOUGLAS
Correspondent
COOPERVISION, INC.
6140 STONERIDGE MALL ROAD
SUITE 500
PLEASANTON,  CA  94588
Correspondent Contact JACK P DOUGLAS
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received06/26/2007
Decision Date 01/04/2008
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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