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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K012873
Device Name DOCUMENTING LASER SLIT LAMP, DP 2010
Applicant
BAUSCH & LOMB, INC.
9342 JERONIMO RD.
IRVINE,  CA  92618
Applicant Contact PENNI L PANNELL
Correspondent
BAUSCH & LOMB, INC.
9342 JERONIMO RD.
IRVINE,  CA  92618
Correspondent Contact PENNI L PANNELL
Regulation Number886.1850
Classification Product Code
HJO  
Date Received08/27/2001
Decision Date 11/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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