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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 K951054
Device Name XCEL SLIT LAMP
Applicant
Leica, Inc.
P.O. Box 123
Buffalo,  NY  14240
Applicant Contact FRANK J DREXELIUM
Correspondent
Leica, Inc.
P.O. Box 123
Buffalo,  NY  14240
Correspondent Contact FRANK J DREXELIUM
Regulation Number886.1850
Classification Product Code
HJO  
Date Received03/07/1995
Decision Date 03/22/1995
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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