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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Analysis, Anterior Segment
510(k) Number K991284
Device Name ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
Applicant
Nidek, Inc.
47651 Westinghouse Dr.
Fremont,  CA  94539
Applicant Contact JERRY TSUTSUMI
Correspondent
Nidek, Inc.
47651 Westinghouse Dr.
Fremont,  CA  94539
Correspondent Contact JERRY TSUTSUMI
Regulation Number886.1850
Classification Product Code
MXK  
Date Received04/15/1999
Decision Date 08/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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