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510(k) K041844

ALL SAFE HUBER SAFETY INFUSION SETS by Nexus Medical, LLC — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2004
Date Received
July 8, 2004
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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  • K081123 — NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS (November 14, 2008)
  • K080976 — NEXUS I.V. FLUID TRANSFER DEVICE (November 10, 2008)

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