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510(k) K141358

CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES by Mauna Kea Technologies — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2014
Date Received
May 23, 2014
Clearance Type
Traditional
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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