FDA 510(k) Application Details - K131208

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K131208
Device Name Lenses, Soft Contact, Daily Wear
Applicant BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547 US
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Contact Barbara Klube-Falso
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 04/29/2013
Decision Date 09/11/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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