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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 K163564
Device Name SLIT LAMP SL-2000
Applicant
NIDEK CO., LTD.
34-14 Maehama, Hiroishicho
Gamagori,  JP 443-0038
Applicant Contact Yoneji Mizuno
Correspondent
NIDEK INC.
47651 Westinghouse Drive
Fremont,  CA  94539
Correspondent Contact Toshio Murata
Regulation Number886.1850
Classification Product Code
HJO  
Date Received12/19/2016
Decision Date 05/19/2017
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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