The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Wire Cutting Pliers Or Lineman's Pliers.
| Device ID | K854390 |
| 510k Number | K854390 |
| Device Name: | WIRE CUTTING PLIERS OR LINEMAN'S PLIERS |
| Classification | Pliers, Surgical |
| 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 | HTC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-31 |
| Decision Date | 1985-11-19 |