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510(k) K161607

VISULUX by Carl Zeiss Meditec, AG — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2017
Date Received
June 10, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

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