LBL — Tube, Tympanostomy, Porous Polyethylene Class II
FDA product code LBL covers "Tube, Tympanostomy, Porous Polyethylene", a Class II medical device regulated under 21 CFR 874.3880. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- LBL
- Device Class
- Class II
- Regulation Number
- 874.3880
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K900218 | j.s. medical assoc | J&S HDL CHOLESTEROL PRECIPITATING REAGENT | June 18, 1990 |