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510(k) K232523

Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% by Mankind Pharma Limited — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2024
Date Received
August 18, 2023
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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