The following data is part of a premarket notification filed by Warne Surgical Products, Ltd. with the FDA for Bush Neck W/plug.
| Device ID | K841409 |
| 510k Number | K841409 |
| Device Name: | BUSH NECK W/PLUG |
| Classification | Trap, Sterile Specimen |
| Applicant | WARNE SURGICAL PRODUCTS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYZ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-05 |
| Decision Date | 1984-04-18 |