C-Flex Septal Splints
FDA 510(k) K952226 · Trebay Medical Corp.
510(k) numberK952226
Submission
- Device name
- C-Flex Septal Splints
- Applicant
- Trebay Medical Corp.
Clearwater, FL, US - Received
- May 12, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYA – Splint, Intranasal Septal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4780
- Specialty
- Ear, Nose, Throat
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| K954912 | Trebay Irrigated Cutter Blade (Modification)EQJ · Traditional | 12/06/1995SE |
| K954795 | AT2 & Doyle Style (C-Flex) Vent TubesETD · Traditional | 11/15/1995SE |
| K954796 | Micro-Ingressor HandipieceERL · Traditional | 11/06/1995SE |
| K954715 | Micro-Planer HandpieceERL · Traditional | 10/27/1995SE |
| K954518 | Trebay Total Rectangular HeadETA · Traditional | 10/27/1995SE |
| K954517 | Trebay Partial Rectrangular Heads, Moretz Cam, Incus/Stapedial Joint & Straight Incus…ETB · Traditional | 10/27/1995SE |
Questions and answers
When was C-Flex Septal Splints cleared by the FDA?
C-Flex Septal Splints (K952226) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 91 days after the submission was received.
What is the product code of K952226?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.