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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Solution, Ultrasonic Cleaners For Lenses
510(k) Number K020802
Device Name RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
Applicant
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14603
Applicant Contact PAUL G STAPLETON
Correspondent
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14603
Correspondent Contact PAUL G STAPLETON
Regulation Number886.5928
Classification Product Code
LYL  
Date Received03/12/2002
Decision Date 05/31/2002
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
Recalls CDRH Recalls
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