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510(k) K110901

SYMBIQ INFUSION AND ADMINSTRATION SET by Hospira, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2012
Date Received
March 31, 2011
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

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  • K160870 — Hospira Administration Sets (June 1, 2016)
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  • K143015 — Hospira Primary Sets (February 25, 2015)
  • K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODU (January 16, 2015)
  • K142622 — IV Administration (January 15, 2015)
  • K142974 — Extension Sets (January 9, 2015)

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