510(k) K944680

SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE by Researched, Novel Medical Devices (Rn/Md) — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1995
Date Received
September 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type