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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 K051477
Device Name MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
Applicant
Mi Gwang Contact Lens Co., Ltd.
2214 Sanford Dr.
B7
Grand Junction,  CO  81505
Applicant Contact MARTIN DALSING
Correspondent
Mi Gwang Contact Lens Co., Ltd.
2214 Sanford Dr.
B7
Grand Junction,  CO  81505
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received06/03/2005
Decision Date 03/10/2006
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
Recalls CDRH Recalls
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