FDA Product Code
FDA Product Code KAC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4420
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K901377 | BARTON-MAYO TRACHEOSTOMA BUTTON | Medical Innovations International, Inc. | 1990-06-14 | Traditional | PDF ↗ |
| K873992 | LARYNGECTOMY TUBE | Portex, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K821993 | SHILEY LARYNGECTOMY TUBE | Shiley, Inc. | 1982-08-12 | Traditional | PDF ↗ |
| K811428 | NORTHWESTERN VOICE RESTORATION KIT | Universal Prosthetics, Inc. | 1981-06-16 | Traditional | PDF ↗ |
Product code KAC · Class I · Ear, Nose, Throat. Data: openFDA.