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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 K120756
Device Name LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
Original Applicant
THE LAGADO CORP.
218 e. commercial blvd
ste # 201-q
lauderdale by the sea,  FL  33308
Original Contact ellen beucler
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/13/2012
Decision Date 05/13/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Clinical Trials NCT01735045
Reviewed by Third Party No
Expedited Review No
Combination Product No
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