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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lens, contact (other material) - daily
510(k) Number K021752
Device Name FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL
Applicant
LUCID KOREA CO., LTD
748 KEOCHON-RI PONGHWA-EUP,
PONGHWA-KUN,
KYUNGSANGBUK-PROVINCE,  KR
Applicant Contact DONG KUN LEE
Correspondent
LUCID KOREA CO., LTD
748 KEOCHON-RI PONGHWA-EUP,
PONGHWA-KUN,
KYUNGSANGBUK-PROVINCE,  KR
Correspondent Contact DONG KUN LEE
Regulation Number886.5916
Classification Product Code
HQD  
Date Received05/28/2002
Decision Date 10/11/2002
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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