Panels › Ear, Nose, Throat › Product code KAC · Class 1
Tube, Laryngectomy
Regulation 874.4420
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in KAC
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Innovations International, Inc. | 1 | 0 |
| Portex, Inc. | 1 | 0 |
| Shiley, Inc. | 1 | 0 |
| Smiths Medical ASD, Inc. | 0 | 1 |
| Universal Prosthetics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2007 | Smiths Medical ASD, Inc. Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L. Terminated |
KAC | None listed |
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