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510(k) K151239

NMI DUAL PORT II by Navilyst Medical, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2016
Date Received
May 11, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

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  • K142616 — PICC Maximal Barrier Nursing Kit (October 14, 2014)
  • K140194 — NAMIC RCS SYRINGE (April 14, 2014)

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