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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 K221517
Device Name POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
Applicant
INTEROJO, Inc.
28& 25 Sandan-Ro 15 Beon-Gil
Pyongtaek-City,  KR 459040
Applicant Contact Si-Chul Rho
Correspondent
Eyereg Consulting, Inc.
6119 Canter Lane
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/25/2022
Decision Date 10/04/2022
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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