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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 K222541
Device Name Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Applicant
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact Melissa Thomas
Correspondent
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact Melissa Thomas
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received08/22/2022
Decision Date 12/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT04175340
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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