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510(k) K140442

MEDSOURCE SELECTABLE IV SET by Medsource International, LLC — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2014
Date Received
February 21, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K080339 — MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) (October 27, 2008)
  • K081516 — MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT (August 26, 2008)

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