Nasal Septal Button
FDA 510(k) K850492 · Santa Barbara Medco, Inc.
510(k) numberK850492
Submission
- Device name
- Nasal Septal Button
- Applicant
- Santa Barbara Medco, Inc.
Santa Barbara, CA, US - Received
- February 8, 1985
- Decision date
- March 7, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K013696 | Silmed Nasal Septal ButtonLFB · Traditional | Silmed, Inc. | 11/28/2001SE |
| 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 |
| K822637 | Nasal Septal ButtonsLFB · Traditional | Abco Dealers, Inc. | 09/28/1982SE |
More from Abco Dealers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842483 | Santa Barbara Medco-Lantophoretic ApplicEGJ · Traditional | 08/31/1984SE |
| K823921 | Physicians Choice Silicone Ear PuttyLDG · Traditional | 03/28/1983SE |
| K821187 | Medco Custom Ear Protector Mold KitEWD · Traditional | 05/27/1982SE |
| K812071 | RK IV Surgical BladesGES · Traditional | 08/31/1981SE |
| K812069 | Bores* Depth GaugeFTY · Traditional | 08/31/1981SE |
| K812070 | Bores* Adjustable Blade HolderGDZ · Traditional | 08/18/1981SE |
| K802638 | Otological Ventilation TubesETD · Traditional | 11/12/1980SE |
Questions and answers
When was Nasal Septal Button cleared by the FDA?
Nasal Septal Button (K850492) received a 510(k) decision of Substantially Equivalent on March 7, 1985, 27 days after the submission was received.
What is the product code of K850492?
The FDA product code is LFB – Button, Nasal Septal, a Unclassified device.