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510(k) K233553

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter by Thayer Medical Corporation — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2024
Date Received
November 6, 2023
Clearance Type
Special
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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  • K111570 — MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR (September 29, 2011)

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