Product code KAC
- Device name
- Tube, Laryngectomy
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4420
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901377 | BARTON-MAYO TRACHEOSTOMA BUTTON | Medical Innovations International, Inc. | 1990-06-14 |
| K873992 | LARYNGECTOMY TUBE | Portex, Inc. | 1988-03-24 |
| K821993 | SHILEY LARYNGECTOMY TUBE | Shiley, Inc. | 1982-08-12 |
| K811428 | NORTHWESTERN VOICE RESTORATION KIT | Universal Prosthetics, Inc. | 1981-06-16 |
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