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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable
510(k) Number K173089
Device Name Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
Applicant
Bausch & Lomb Incorporated
1400 N. Goodman St.
Rodchester,  NY  14609
Applicant Contact Melissa Thomas
Correspondent
Bausch & Lomb Incorporated
1400 N. Goodman St.
Rodchester,  NY  14609
Correspondent Contact Melissa Thomas
Regulation Number886.5918
Classification Product Code
MRC  
Date Received09/29/2017
Decision Date 11/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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