K822618 is an FDA 510(k) clearance for the EMERGENCY TRACHEOSTOMY INSTRUMENT SET. This device is classified as a Tracheotome (Class I - General Controls, product code LJW).
Submitted by Kelleher Corp. (Richmond, US). The FDA issued a Cleared decision on January 28, 1983, 148 days after receiving the submission on September 2, 1982.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K822618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1982 |
| Decision Date | January 28, 1983 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | LJW — Tracheotome |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |