Nasal Septal Button
FDA 510(k) K972060 · Boston Medical Products, Inc.
510(k) numberK972060
Submission
- Device name
- Nasal Septal Button
- Applicant
- Boston Medical Products, Inc.
Westborough, MA, US - Received
- June 2, 1997
- Decision date
- July 3, 1997
- 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 |
| K013696 | Silmed Nasal Septal ButtonLFB · Traditional | Silmed, Inc. | 11/28/2001SE |
| K982667 | Micromedics Nasal Septal ButtonLFB · Traditional | Micromedics, Inc. | 11/24/1998SE |
| 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 |
More from Abco Dealers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K091135 | Rutter Supra Stomal StentsFWN · Traditional | 09/14/2009SE |
| K972317 | Montgomery Thyroplasty Implant SystemMIX · Traditional | 09/18/1997SE |
| K972459 | Rhinocell Nasal PackingsEMX · Traditional | 08/04/1997SE |
| K972096 | Bivalve Nasal SplintLYA · Traditional | 07/15/1997SE |
| K972078 | Post-Stop Epistaxis CatheterEMX · Traditional | 07/10/1997SE |
| K972092 | Nasal Airway SplintLYA · Traditional | 07/08/1997SE |
| K972151 | Doyle Combo Nasal Airway SplintLYA · Traditional | 07/07/1997SE |
| K972082 | Custom Nasal SplintLYA · Traditional | 07/03/1997SE |
| K972077 | Epi-Stop Epistaxis CatheterEMX · Traditional | 06/26/1997SE |
| K972076 | Epi-Max Epistaxis CatheterEMX · Traditional | 06/26/1997SE |
Questions and answers
When was Nasal Septal Button cleared by the FDA?
Nasal Septal Button (K972060) received a 510(k) decision of Substantially Equivalent on July 3, 1997, 31 days after the submission was received.
What is the product code of K972060?
The FDA product code is LFB – Button, Nasal Septal, a Unclassified device.