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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 K111345
Device Name SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
Applicant
THE SEE CLEAR COMPANY, INC
16576 W. 53rd way
Golden,  CO  80403
Applicant Contact KEVIN RANDALL
Correspondent
THE SEE CLEAR COMPANY, INC
16576 W. 53rd way
Golden,  CO  80403
Correspondent Contact KEVIN RANDALL
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/13/2011
Decision Date 11/02/2011
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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