Invotec Septal Button
FDA 510(k) K901366 · Invotec International, Inc.
510(k) numberK901366
Submission
- Device name
- Invotec Septal Button
- Applicant
- Invotec International, Inc.
Jacksonville, FL, US - Received
- March 23, 1990
- Decision date
- June 14, 1990
- 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 |
| 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 |
|---|---|---|
| K122040 | Invotec Laryngeal ElectrodeETN · Traditional | 10/31/2013SE |
| K080740 | Clearview Endoscope CoverEOB · Traditional | 12/31/2008SE |
| K030492 | Titanium Ossicular Replacment SystemETA · Traditional | 03/03/2003SE |
| K973580 | Invotec Clean PadEFQ · Traditional | 12/10/1997SE |
| K973578 | Invotec Ear Tampon (Wick) W/StringKCN · Traditional | 11/06/1997SE |
| K971000 | Epistaxis Nasal PackEMX · Traditional | 05/14/1997SE |
| K930114 | Tracheostomy T-TubeBTR · Traditional | 03/19/1993SE |
| K911041 | Invotec X-Ray Cassette Equipment DrapeIXA · Traditional | 06/04/1991SE |
| K911040 | Invotec Microscope DrapeHMW · Traditional | 06/03/1991SE |
| K911039 | Invotec Ear DrapeKKX · Traditional | 05/13/1991SE |
Questions and answers
When was Invotec Septal Button cleared by the FDA?
Invotec Septal Button (K901366) received a 510(k) decision of Substantially Equivalent on June 14, 1990, 83 days after the submission was received.
What is the product code of K901366?
The FDA product code is LFB – Button, Nasal Septal, a Unclassified device.