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510(k) K200063

AeroEclipse* ONE BAN by Trudell Medical International — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2020
Date Received
January 13, 2020
Clearance Type
Abbreviated
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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