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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 1990 | K901377 | BARTON-MAYO TRACHEOSTOMA BUTTON Medical Innovations International, Inc. | KAC |
| Mar 24, 1988 | K873992 | LARYNGECTOMY TUBE Portex, Inc. | KAC |
| Aug 12, 1982 | K821993 | SHILEY LARYNGECTOMY TUBE Shiley, Inc. | KAC |
| Jun 16, 1981 | K811428 | NORTHWESTERN VOICE RESTORATION KIT Universal Prosthetics, Inc. | KAC |
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