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510(k) K231707

ResQ Administration Set by Q For Plastic Industries — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2024
Date Received
June 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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