The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for General Surgical Files.
| Device ID | K844145 |
| 510k Number | K844145 |
| Device Name: | GENERAL SURGICAL FILES |
| Classification | File, Surgical, General & Plastic Surgery |
| Applicant | MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
| Contact | John M Mayerik |
| Correspondent | John M Mayerik MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
| Product Code | GEO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1984-11-20 |