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510(k) K212695

KARL STORZ ICG Imaging System by Karl Storz Endoscopy America — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2021
Date Received
August 25, 2021
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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