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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 K142275
Device Name Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
Applicant
Neo Vision Co., Ltd.
1029 Yeongdoek-Dong, Gihenung-Gu
Yongin-Si 17th Floor, 4-Tower
Gyeonggi-Do,  KR
Applicant Contact Kyung Hwa Kim
Correspondent
Albert Rego PHD
27001 La Paz Rd.
Suite 312
Mission Viejo,  CA  92691
Correspondent Contact Albert Rego
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/15/2014
Decision Date 10/07/2014
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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