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

K944680 is an FDA 510(k) premarket notification submitted by Researched, Novel Medical Devices (Rn/Md) for the device "SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE". The FDA issued a decision of Substantially Equivalent on January 31, 1995. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Researched, Novel Medical Devices (Rn/Md) has at least 2 other 510(k) clearances on record.

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