FDA 510(k) Application Details - K173089

Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable

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510(K) Number K173089
Device Name Products, Contact Lens Care, Rigid Gas Permeable
Applicant Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, NY 14609 US
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Contact Melissa Thomas
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Regulation Number 886.5918

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Classification Product Code MRC
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Date Received 09/29/2017
Decision Date 11/27/2017
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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