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510(k) K171118

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) by Cair Lgl — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2017
Date Received
April 14, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K171117 — Carefusion NeutraClear Needle-free connector (EL-NC1000) (September 1, 2017)
  • K171132 — Carefusion NeutraClear Needle-free connector (July 31, 2017)
  • K133073 — CAIR DRIVE, NEUTRACLEAR (March 20, 2014)

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