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510(k) K203400

Corrugated tube with mouthpiece accessory by Trudell Medical International — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2021
Date Received
November 19, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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