(84 days)
Scalp Vein Set: intended to be used for insertion into the patient's vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
Sterile hypodermic needles for single use: intended for use to inject or withdraw fluids from the body.
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This document is a 510(k) premarket notification decision letter for a medical device called "Scalp Vein Set for Single Use Sterile Hypodermic Needles for Single Use." It does not contain information about acceptance criteria or a study proving device performance as requested. All the information in the provided text relates to regulatory approval, product codes, and indications for use, not performance studies. Therefore, I cannot generate the requested table and study information from the given input.
§ 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).