The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Combination Wrenches.
| Device ID | K874358 |
| 510k Number | K874358 |
| Device Name: | COMBINATION WRENCHES |
| Classification | Wrench |
| Applicant | MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
| Contact | John Mayerik |
| Correspondent | John Mayerik MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
| Product Code | HXC |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-23 |
| Decision Date | 1987-11-23 |