KAC — Tube, Laryngectomy Class I
FDA Device Classification
Classification Details
- Product Code
- KAC
- Device Class
- Class I
- Regulation Number
- 874.4420
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K901377 | medical innovations international | BARTON-MAYO TRACHEOSTOMA BUTTON | June 14, 1990 |
| K873992 | portex | LARYNGECTOMY TUBE | March 24, 1988 |
| K821993 | shiley | SHILEY LARYNGECTOMY TUBE | August 12, 1982 |
| K811428 | universal prosthetics | NORTHWESTERN VOICE RESTORATION KIT | June 16, 1981 |