510(k) K072511

SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM by Medimop Medical Projects, Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2007
Date Received
September 6, 2007
Clearance Type
Abbreviated
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