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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 K943784
Device Name MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR
Applicant
MENICON CO. LTD.
700 THIRTEENTH STREET, N.W.,
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact A. WES SIEGNER
Correspondent
MENICON CO. LTD.
700 THIRTEENTH STREET, N.W.,
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact A. WES SIEGNER
Regulation Number886.5916
Classification Product Code
HQD  
Date Received07/26/1994
Decision Date 10/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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