Silmed Nasal Septal Button
FDA 510(k) K013696 · Silmed, Inc.
510(k) numberK013696
Submission
- Device name
- Silmed Nasal Septal Button
- Applicant
- Silmed, Inc.
Leesburg,, IN, US - Received
- November 7, 2001
- Decision date
- November 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFB – Button, Nasal Septal
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code LFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131745 | Blom-Singer Septal Perforation ProsthesisLFB · Traditional | Helix Medical, LLC | 09/17/2013SE |
| K982667 | Micromedics Nasal Septal ButtonLFB · Traditional | Micromedics, Inc. | 11/24/1998SE |
| K972060 | Nasal Septal ButtonLFB · Traditional | Boston Medical Products, Inc. | 07/03/1997SE |
| K920994 | Hood Nasal Septal ButtonLFB · Traditional | Hood Laboratories | 05/15/1992SE |
| K901366 | Invotec Septal ButtonLFB · Traditional | Invotec International, Inc. | 06/14/1990SE |
| K871072 | Omega Nasal Septal ButtonLFB · Traditional | Omega Silicone, Inc. | 06/08/1987SE |
| K871200 | Cui Nasal Septum ButtonLFB · Traditional | Cox-Uphuff Intl. | 04/15/1987SE |
| K862497 | Microtek Septal ButtonLFB · Traditional | Microtek Medical, Inc. | 07/14/1986SE |
| K850492 | Nasal Septal ButtonLFB · Traditional | Santa Barbara Medco, Inc. | 03/07/1985SE |
| K822637 | Nasal Septal ButtonsLFB · Traditional | Abco Dealers, Inc. | 09/28/1982SE |
Questions and answers
When was Silmed Nasal Septal Button cleared by the FDA?
Silmed Nasal Septal Button (K013696) received a 510(k) decision of Substantially Equivalent on November 28, 2001, 21 days after the submission was received.
What is the product code of K013696?
The FDA product code is LFB – Button, Nasal Septal, a Unclassified device.