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FDA 510(k) Application Details - K200893
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K200893
Device Name
Set, I.V. Fluid Transfer
Applicant
IPAX, Inc
2700 S Raritan St
Englewood, CO 80110 US
Other 510(k) Applications for this Company
Contact
Jeff Baldwin
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
LHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/03/2020
Decision Date
05/04/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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