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510(k) K991284

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM by Nidek, Inc. — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1999
Date Received
April 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

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