Pump-Ject Syringe with Luer-Lock
FDA 510(k) K894041 · Ziehm International, Inc.
510(k) numberK894041
Submission
- Device name
- Pump-Ject Syringe with Luer-Lock
- Applicant
- Ziehm International, Inc.
South El Monte, CA, US - Received
- June 6, 1989
- Decision date
- August 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K831407 | Cardiac Output ComputerDXG · Traditional | 10/14/1983SE |
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Questions and answers
When was Pump-Ject Syringe with Luer-Lock cleared by the FDA?
Pump-Ject Syringe with Luer-Lock (K894041) received a 510(k) decision of Substantially Equivalent on August 28, 1989, 83 days after the submission was received.
What is the product code of K894041?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.