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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 -0450
Applicant Contact PAUL G STAPLETON
Correspondent
BAUSCH & LOMB INCORPORATED
1400 N. GOODMAN ST.
ROCHESTER,  NY  14603 -0450
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
Recalls CDRH Recalls
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