The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Half Round File.
| Device ID | K840980 |
| 510k Number | K840980 |
| Device Name: | HALF ROUND FILE |
| Classification | Pliers, Surgical |
| Applicant | MED-TOOL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-06 |
| Decision Date | 1984-04-25 |