K841409 is an FDA 510(k) clearance for the BUSH NECK W/PLUG. This device is classified as a Trap, Sterile Specimen (Class II - Special Controls, product code BYZ).
Submitted by Warne Surgical Products, Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1984, 13 days after receiving the submission on April 5, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K841409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1984 |
| Decision Date | April 18, 1984 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | BYZ — Trap, Sterile Specimen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |