Double-Ject Transfer Needle

FDA 510(k) K860113 · Medimix Products, Inc.

Substantially Equivalent

510(k) numberK860113

Submission

Device name
Double-Ject Transfer Needle
Applicant
Medimix Products, Inc.
Napa, CA, US
Received
January 13, 1986
Decision date
February 12, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LHI – Set, I.V. Fluid Transfer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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Questions and answers

When was Double-Ject Transfer Needle cleared by the FDA?

Double-Ject Transfer Needle (K860113) received a 510(k) decision of Substantially Equivalent on February 12, 1986, 30 days after the submission was received.

What is the product code of K860113?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.