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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 K211448
Device Name Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
Applicant
Pegavision Corporation
2f-1, # 5, Shing Yeh St., Guishan Dist.
Taoyuan City,  TW 33341
Applicant Contact Estela Lin
Correspondent
Pegavision Corporation
2f-1, # 5, Shing Yeh St., Guishan Dist.
Taoyuan City,  TW 33341
Correspondent Contact Estela Lin
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received05/10/2021
Decision Date 12/06/2021
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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