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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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