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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 K181656
Device Name ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
Applicant
Eyemed Technologies S.r.l.
Via al Boscaccio 3
Casorate Sempione,  IT 21011
Applicant Contact Franco Ceravolo
Correspondent
Eyemed Technologies S.r.l.
Via al Boscaccio 3
Casorate Sempione,  IT 21011
Correspondent Contact Franco Ceravolo
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received06/22/2018
Decision Date 03/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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