FDA 510(k) Application Details - K183167

Device Classification Name Lens, Contact (Other Material) - Daily

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510(K) Number K183167
Device Name Lens, Contact (Other Material) - Daily
Applicant Bausch & Lomb, Incorporated
1400 North Goodman Street
Rochester, NY 14609 US
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Contact Glenn A. Davies
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Regulation Number 886.5916

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Classification Product Code HQD
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Date Received 11/15/2018
Decision Date 02/12/2019
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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