ML Universal Tubing
FDA 510(k) K983448 · Med-Logics, Inc.
510(k) numberK983448
Submission
- Device name
- ML Universal Tubing
- Applicant
- Med-Logics, Inc.
Laguna Niguel, CA, US - Received
- September 30, 1998
- Decision date
- December 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MSR – Tubing, Replacement, Phacofragmentation Unit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
Other 510(k)s with product code MSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993361 | Tubing Extension SetMSR · Traditional | Hurricane Medical | 01/04/2000SE |
| K980849 | Surgin KitMSR · Traditional | Surgin Surgical Instrumentation, Inc. | 07/09/1998SE |
| K980100 | Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc DaypackMSR · Traditional | Storz Instrument Co. | 06/01/1998SE |
| K972522 | Ml-Disposable PakMSR · Traditional | Med-Logics, Inc. | 09/30/1997SE |
More from Med-Logics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033293 | Med-Logics, Model ML7090HNO · Traditional | 01/13/2004SE |
| K022982 | Med-Logics Microkeratome Blade, Model 7050CLBHNO · Traditional | 11/15/2002SE |
| K022716 | Med-Logics Microkeratome Blade, Model 7020CLBHNO · Traditional | 10/11/2002SE |
| K010872 | ML Blade, Model ML7030HNO · Traditional | 06/22/2001SE |
| K010353 | Med-Logics Disposable Alk TubingKYG · Traditional | 04/27/2001SE |
| K002515 | Medlogics ML 4000, Model 4000HNO · Traditional | 02/22/2001SE |
| K002279 | ML Eye Spear, Model ML 27 EsHOZ · Traditional | 08/18/2000SE |
| K981071 | ML MicrokeratomeHNO · Traditional | 07/23/1998SE |
| K972522 | Ml-Disposable PakMSR · Traditional | 09/30/1997SE |
| K971173 | ML Disposable Alk TubingKYG · Traditional | 05/22/1997SE |
Questions and answers
When was ML Universal Tubing cleared by the FDA?
ML Universal Tubing (K983448) received a 510(k) decision of Substantially Equivalent on December 18, 1998, 79 days after the submission was received.
What is the product code of K983448?
The FDA product code is MSR – Tubing, Replacement, Phacofragmentation Unit, a Class II (moderate risk) device regulated under 21 CFR 886.4150.