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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 K210609
Device Name AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
VP Optics
D-611, 17, Techno 4-ro
daejeon,  KR
Applicant Contact daniel yoon
EyeReg Consulting Inc.
6119 Canter Lane
west linn,  OR  97068
Correspondent Contact bret andre
Regulation Number886.5925
Classification Product Code
Subsequent Product Code
Date Received03/01/2021
Decision Date 04/27/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No