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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 K862515
Device Name BAUSCH & LOMB CSL-1000 SLIT LAMP
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Applicant Contact NICHOLAS A WALP
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Correspondent Contact NICHOLAS A WALP
Regulation Number886.1850
Classification Product Code
HJO  
Date Received07/01/1986
Decision Date 07/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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