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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K161819
Device Name NNR06 Multi-Purpose Solution
Applicant
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact Glenn Davies
Correspondent
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact Glenn Davies
Regulation Number886.5928
Classification Product Code
LPN  
Date Received07/01/2016
Decision Date 11/25/2016
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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