K Number
K955235Device Name
B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
Date Cleared
1996-02-12
(90 days)
Product Code
Regulation Number
880.5570AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
N/A