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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 K121652
Device Name CVUE ADVANCED HYDRA VUE
Original Applicant
UNILENS CORP., USA
10431 72nd st. north
largo,  FL  33777
Original Contact alan j frazer
Regulation Number886.5925
Classification Product Code
LPL  
Date Received06/05/2012
Decision Date 10/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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