Microtek Reuter-Style Bi-Valve Intranasal Splint
FDA 510(k) K895502 · Microbio-Medics, Inc.
510(k) numberK895502
Submission
- Device name
- Microtek Reuter-Style Bi-Valve Intranasal Splint
- Applicant
- Microbio-Medics, Inc.
Columbus, MS, US - Received
- September 12, 1989
- Decision date
- December 8, 1989
- 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 |
| 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 |
| K863382 | Cannon Nasal SplintEPP · Traditional | Treace Medical, Inc. | 10/07/1986SE |
More from Treace Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923353 | Ventilation Tubes W/ Hydrogel CoatingETD · Traditional | 05/18/1993SE |
| K922572 | 321Q Minimum Energy Tinnitus SuppressorKLW · Traditional | 11/02/1992SE |
| K913276 | Microtek Medical's Sound StiksEWO · Traditional | 10/21/1991SE |
| K904239 | Soft Hydroxylapatite Ossicular Malleable ProsthesETA · Traditional | 06/21/1991SE |
| K910167 | Microtek-Heritages Silicone Bulb Evacuation SystemGCY · Traditional | 04/15/1991SE |
| K900726 | Microtek Medical's Blood Collection KitJKA · Traditional | 05/04/1990SE |
| K901154 | Microtek's Surgical Lamp Handle & CoverFTA · Traditional | 03/20/1990SE |
| K895815 | Microtek Total Ossicular ProthesisETA · Traditional | 12/26/1989SE |
| K895814 | Microtek Piston & Wire ProsthesesETB · Traditional | 12/26/1989SE |
| K885201 | Ossicular Prostheses 4 Partial, 4 Total, 2 ConvertETA · Traditional | 04/19/1989SE |
Questions and answers
When was Microtek Reuter-Style Bi-Valve Intranasal Splint cleared by the FDA?
Microtek Reuter-Style Bi-Valve Intranasal Splint (K895502) received a 510(k) decision of Substantially Equivalent on December 8, 1989, 87 days after the submission was received.
What is the product code of K895502?
The FDA product code is EPP – Splint, Nasal, a Class I (low risk) device regulated under 21 CFR 874.5800.