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510(k) K231854

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM by Stryker — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2023
Date Received
June 23, 2023
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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