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510(k) K221611

780 nm L11 LED Light Source with AIM by Stryker — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2022
Date Received
June 3, 2022
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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