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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
Applicant
VP Optics
D-611, 17, Techno 4-ro
daejeon,  KR
Applicant Contact daniel yoon
Correspondent
EyeReg Consulting Inc.
6119 Canter Lane
west linn,  OR  97068
Correspondent Contact bret andre
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
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
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