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510(k) K181360

ON-Q* Pump with Bolus by Halyard Health — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2019
Date Received
May 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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