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510(k) K082836

ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES by Icu Medical, Inc. — Product Code FMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2009
Date Received
September 26, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
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