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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 K122220
Device Name ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
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 03/19/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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