FDA 510(k) Application Details - K151918

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K151918
Device Name Lenses, Soft Contact, Daily Wear
Applicant BAUSCH & LOMB INCORPORATED
1400 North Goodman Street
Rochester, NY 14609 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 07/13/2015
Decision Date 02/11/2016
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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