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510(k) K141789

PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE by Hospira, Inc. — Product Code FRN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 16, 2015
Date Received: July 2, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

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

Other clearances by Hospira, Inc.

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K160870 — Hospira Administration Sets (June 1, 2016)
K143612 — LifeCare PCA Infusion System (April 8, 2016)
K143087 — Hospira Blood Set (March 4, 2015)
K143015 — Hospira Primary Sets (February 25, 2015)
K142622 — IV Administration (January 15, 2015)
K142974 — Extension Sets (January 9, 2015)
K142433 — Hospira Extension Set (December 8, 2014)

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