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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 K120028
Device Name AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
Original Applicant
PEGAVISION CORPORATION
2f-1 no.5, shing yeh st.
shan ding vil.
taoyuan,  TW 33341
Original Contact tony hsu
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received01/10/2012
Decision Date 04/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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