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510(k) K173980

Specular Microscope CEM-530 by Nidek Co., Ltd. — Product Code NQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2018
Date Received
December 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Specular
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.

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