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510(k) K190630

SolidAIRity III Airway Stabilization System by Securisyn Medical, LLC — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2019
Date Received
March 12, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

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