510(k) K120424

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2012
Date Received
February 13, 2012
Clearance Type
Traditional
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