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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
510(k) Number K792083
Device Name HAAG-STREIT SLIT LAMP 900
Applicant
LUMENIS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LUMENIS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4700
Classification Product Code
HRM  
Date Received10/16/1979
Decision Date 11/16/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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