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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 K121201
Device Name SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
Original Applicant
ST. SHINE OPTICAL CO., LTD.
4,5 f/l no. 276-2 sec. 1
tatung rd.,hsi chin dist
new taipei city,  TW 221
Original Contact ella lee
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received04/19/2012
Decision Date 10/26/2012
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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