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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 K122213
Device Name ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Original Applicant
SOFLEX LIMITED
33 golden eagle lane
littleton,  CO  80127
Original Contact kevin walls
Regulation Number886.5925
Classification Product Code
LPL  
Date Received07/25/2012
Decision Date 12/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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