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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 K132216
Device Name BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
Applicant
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact SAMANTHA DUFFY
Correspondent
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact SAMANTHA DUFFY
Regulation Number886.5928
Classification Product Code
LPN  
Date Received07/17/2013
Decision Date 09/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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