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510(k) K111047

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2011
Date Received
April 15, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

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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