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510(k) K160327

ALADDIN HW3.0 by Visia Imaging S.R.L. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2016
Date Received
February 5, 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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