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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 K160472
Device Name Hidrocor, Hidrocharme, and Natural Colors
Applicant
Solotica
R Domingos Fasolari 110 -Casa Verde
São Paulo,  BR 02513-010
Applicant Contact Gilberto Zablith
Correspondent
Licensale, Inc.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact Ray Kelly
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
HQD  
Date Received02/19/2016
Decision Date 08/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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