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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 K122575
Device Name BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
Original Applicant
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester,  NY  14609 -3547
Original Contact nancy a fehrman
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/23/2012
Decision Date 12/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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