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510(k) K201026

sOLVe Tube by Hytek Medical, Inc. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2021
Date Received
April 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type

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