'Exmoor' Atkins Nasal Splint
FDA 510(k) K864930 · Exmoor Plastics , Ltd.
510(k) numberK864930
Submission
- Device name
- 'Exmoor' Atkins Nasal Splint
- Applicant
- Exmoor Plastics , Ltd.
Taunton, GB - Received
- December 16, 1986
- Decision date
- March 4, 1987
- 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 |
| K864934 | 'Exmoor' Shah Silicone DiscsEPP · Traditional | Exmoor Plastics , Ltd. | 01/28/1987SE |
| K863382 | Cannon Nasal SplintEPP · Traditional | Treace Medical, Inc. | 10/07/1986SE |
More from Treace Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K093863 | EpidrumFMF · Traditional | 05/10/2010SE |
| K990366 | Exmoor Suction Clearance KitLRC · Traditional | 03/05/1999SE |
| K980828 | Exmoor Myringotomy KitETD · Traditional | 10/22/1998SE |
| K981143 | Dilkes Laser/Suction CannulaeGEX · Traditional | 09/14/1998SE |
| K972700 | Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD Facs Pattern)KHJ · Traditional | 07/16/1998SE |
| K981088 | Mills Columella ProsthesisETA · Traditional | 06/05/1998SE |
| K981045 | Exmoor Teflon Loop Replacement ProsthesisETB · Traditional | 05/20/1998SE |
| K974008 | Pfleiderer's Intratympanic CatheterETD · Traditional | 05/13/1998SE |
| K974224 | Endolymphatic Sac to Mastoid T-ShuntESZ · Traditional | 01/27/1998SE |
| K973587 | Exmoor Tympanocentesis Kit (TK/1)JZF · Traditional | 01/23/1998SE |
Questions and answers
When was 'Exmoor' Atkins Nasal Splint cleared by the FDA?
'Exmoor' Atkins Nasal Splint (K864930) received a 510(k) decision of Substantially Equivalent on March 4, 1987, 78 days after the submission was received.
What is the product code of K864930?
The FDA product code is EPP – Splint, Nasal, a Class I (low risk) device regulated under 21 CFR 874.5800.