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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 K131378
Device Name SUS (STENFILCON A) CONTACT LENS
Applicant
COOPERVISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton,  CA  94588
Applicant Contact ANNETTE NELSON
Correspondent
COOPERVISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton,  CA  94588
Correspondent Contact ANNETTE NELSON
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received05/14/2013
Decision Date 08/30/2013
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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