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510(k) K092527

NEXUS INJECTION SITE, MODEL NIS-8 by Nexus Medical, LLC — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2010
Date Received
August 18, 2009
Clearance Type
Special
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)
  • K062551 — NEXUS IRRIGATION TUBING SET (December 15, 2006)

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