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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 K162317
Device Name Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
Applicant
St. shine Optical Co., Ltd.
4,5f # 276-2, Sec. 1, Ta Tung Rd.,Hsi Chih Dist.
New Taipei City,  TW 22146
Applicant Contact ELLA LEE
Correspondent
St. shine Optical Co., Ltd.
4,5f # 276-2, Sec. 1, Ta Tung Rd.,Hsi Chih Dist.
New Taipei City,  TW 22146
Correspondent Contact ELLA LEE
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received08/19/2016
Decision Date 10/21/2016
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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