510(k) K101309

EXELINT ALUMINUM HUB BLUNT NEEDLES by Exelint International, Co. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2010
Date Received
May 10, 2010
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