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510(k) K220854

TrachCuff Cuff Controller by Aw Technologies Aps — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2023
Date Received
March 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

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