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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 K140025
Device Name AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
Applicant
Pegavision Corporation
2f-1 #5, Shing Yeh St.
Shan Ding Vil.
Taoyuan,  TW 33341
Applicant Contact TONY HSU
Correspondent
Pegavision Corporation
2f-1 # 5, Shing Yeh St. Shan Ding Vil Kwei Shan
Hsiang, Taoyuan Hsien,  TW 333
Correspondent Contact Tony Hsu
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received01/06/2014
Decision Date 10/15/2014
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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