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510(k) K210126

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% by The Ritedose Corporation — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2021
Date Received
January 19, 2021
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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