Goode Magnetic Nasal Splint
FDA 510(k) K810738 · Xomed, Inc.
510(k) numberK810738
Submission
- Device name
- Goode Magnetic Nasal Splint
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- March 18, 1981
- Decision date
- March 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EPP – Splint, Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5800
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EPP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942158 | Aquaplast Nasal Splints, Precut Silver Splint Patterns and Splint KitsEPP · Traditional | Wfr/Aquaplast Corp. | 07/29/1994SE |
| K942724 | External Nasal SplintEPP · Traditional | Micromed Development Corp. | 07/08/1994SE |
| K895502 | Microtek Reuter-Style Bi-Valve Intranasal SplintEPP · Traditional | Microbio-Medics, Inc. | 12/08/1989SE |
| K890599 | Hood Nasal SplintEPP · Traditional | Hood Laboratories | 03/17/1989SE |
| K882244 | Richards Thermoplastic Dorsal Nasal SplintEPP · Traditional | Richards Medical Co., Inc. | 06/23/1988SE |
| K872905 | American Nasal SpongeEPP · Traditional | American Silk Sutures, Inc. | 09/04/1987SE |
| K864933 | 'Exmoor' Shah & Mackay Nasal SplintsEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864932 | 'Exmoor' Cawood Nasal SplintsEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864930 | 'Exmoor' Atkins Nasal SplintEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864934 | 'Exmoor' Shah Silicone DiscsEPP · Traditional | Exmoor Plastics , Ltd. | 01/28/1987SE |
More from Exmoor Plastics , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
| K002987 | Redtronic Xomed Monopolar Energized BladeGEI · Traditional | 12/04/2000SE |
| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Goode Magnetic Nasal Splint cleared by the FDA?
Goode Magnetic Nasal Splint (K810738) received a 510(k) decision of Substantially Equivalent on March 31, 1981, 13 days after the submission was received.
What is the product code of K810738?
The FDA product code is EPP – Splint, Nasal, a Class I (low risk) device regulated under 21 CFR 874.5800.