The following data is part of a premarket notification filed by Warne Surgical Products, Ltd. with the FDA for Rolled Neck W/tap.
| Device ID | K841412 |
| 510k Number | K841412 |
| Device Name: | ROLLED NECK W/TAP |
| Classification | Bag, Reservoir |
| Applicant | WARNE SURGICAL PRODUCTS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTC |
| CFR Regulation Number | 868.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-05 |
| Decision Date | 1984-04-18 |