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510(k) K160416

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes by Mauna Kea Technologies — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2016
Date Received
February 16, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

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