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510(k) K232293

kallisio stentra™ oral stent by Kallisio, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
August 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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