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510(k) Data Aggregation

K Number

K061032

Device Name

DEPOTONE

Manufacturer

IMPRINT PHARMACEUTICALS LIMITED

Date Cleared

2006-06-21

(68 days)

Product Code

FMI

Regulation Number

880.5570

Intended Use

DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.

Device Description

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K Number

K050505

Device Name

DEPOTONE

Manufacturer

IMPRINT PHARMACEUTICALS LIMITED

Date Cleared

2005-04-05

(36 days)

Product Code

FMI

Regulation Number

880.5570

Intended Use

DepotOne is a sterile single use hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.

Device Description

The DepotOne needles comprise of a length of Hypodermic grade stainless steel tube connected to a female connector (hub) that is designed to mate with a male connector of a piston syringe or an intravascular administration set. The other end of the tube is sharpened with a lancet tip in accordance with ISO7864: 1993. The sharpened section of tube is of a reduced diameter. The fluid is injected or removed through a side aperture adjacent to the sharpened tip.

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