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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 K083757
Device Name BPZ02 MULTIPURPOSE SOLUTION
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14609 -3547
Applicant Contact GLENN A DAVIES, O.D.
Correspondent
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14609 -3547
Correspondent Contact GLENN A DAVIES, O.D.
Regulation Number886.5928
Classification Product Code
LYL  
Date Received12/17/2008
Decision Date 11/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT00636363
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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