Unifine Pentips
FDA 510(k) K973899 · Owen Mumford USA, Inc.
510(k) numberK973899
Submission
- Device name
- Unifine Pentips
- Applicant
- Owen Mumford USA, Inc.
Marietta, GA, US - Received
- October 14, 1997
- Decision date
- December 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
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| K983994 | UnifineFMF · Traditional | 01/08/1999SE |
| K983974 | Owen Mumford 3ML AutopenFMF · Traditional | 12/21/1998SE |
| K982275 | Rapport V.T.D.LKY · Traditional | 12/04/1998SE |
| K983045 | AmielleKXP · Traditional | 11/25/1998SE |
| K971443 | Rapport V.T.D.LKY · Traditional | 09/26/1997SE |
| K953735 | Autoject MiniKZH · Traditional | 11/08/1995SE |
| K945660 | Autoject 2KZH · Traditional | 08/11/1995SE |
Questions and answers
When was Unifine Pentips cleared by the FDA?
Unifine Pentips (K973899) received a 510(k) decision of Substantially Equivalent on December 4, 1997, 51 days after the submission was received.
What is the product code of K973899?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.