K873992 is an FDA 510(k) clearance for the LARYNGECTOMY TUBE. This device is classified as a Tube, Laryngectomy (Class I - General Controls, product code KAC).
Submitted by Portex, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 24, 1988, 175 days after receiving the submission on October 1, 1987.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K873992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1987 |
| Decision Date | March 24, 1988 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | KAC — Tube, Laryngectomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |