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510(k) K132276

STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML by Hospira, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2013
Date Received
July 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

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  • K143015 — Hospira Primary Sets (February 25, 2015)
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  • K142622 — IV Administration (January 15, 2015)
  • K142974 — Extension Sets (January 9, 2015)

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