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FDA 510(k) Application Details - K220955
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K220955
Device Name
Nebulizer (Direct Patient Interface)
Applicant
Medline Industires, Inc.
1 Three Lakes Drive
Northfield, IL 60093 US
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Contact
Nicole Schaffer
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Regulation Number
868.5630
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Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
04/01/2022
Decision Date
06/23/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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