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510(k) K232552

TuxDeluxe (Size 1 6100B, Size 2 6101B) by Tuxedo Imaging, LLC — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2023
Date Received
August 23, 2023
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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