510(k) K982667
- Device
- MICROMEDICS NASAL SEPTAL BUTTON
- Applicant
- MICROMEDICS, INC.
- 510(k) number
- K982667
- Product code
- LFB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-11-24
- Date received
- 1998-07-31
- Regulation
- 510(k) Premarket Notification
- Classification name
- Button, Nasal Septal
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ear Nose & Throat
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES GROTE
- Address
- 1285 Corporate Center Dr., #150 Eagan MN US 55121 55121
FDA Registration Numbers#
- 3008719017
- 1052728
- 9612501
- 2025182
- 1219795
- 3018094310
- 1926681
- 2183762
- 2183744
- 3017636737
- 1220850
- 1045254
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131745 | BLOM-SINGER SEPTAL PERFORATION PROSTHESIS | Helix Medical, LLC | 2013-09-17 |
| K013696 | SILMED NASAL SEPTAL BUTTON | Silmed, Inc. | 2001-11-28 |
| K972060 | NASAL SEPTAL BUTTON | Boston Medical Products, Inc. | 1997-07-03 |
| K920994 | HOOD NASAL SEPTAL BUTTON | Hood Laboratories | 1992-05-15 |
| K901366 | INVOTEC SEPTAL BUTTON | Invotec International, Inc. | 1990-06-14 |
| K871072 | OMEGA NASAL SEPTAL BUTTON | Omega Silicone, Inc. | 1987-06-08 |
| K871200 | CUI NASAL SEPTUM BUTTON | Cox-Uphuff Intl. | 1987-04-15 |
| K862497 | MICROTEK SEPTAL BUTTON | Microtek Medical, Inc. | 1986-07-14 |
| K850492 | NASAL SEPTAL BUTTON | Santa Barbara Medco, Inc. | 1985-03-07 |
| K822637 | NASAL SEPTAL BUTTONS | Abco Dealers, Inc. | 1982-09-28 |
| K781529 | SEPTAL BUTTON | Xomed, Inc. | 1978-10-17 |
Legacy Summary#
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FDA Review#
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