The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Parallel Action Pliers.
| Device ID | K861953 |
| 510k Number | K861953 |
| Device Name: | PARALLEL ACTION PLIERS |
| Classification | Pliers, Surgical |
| Applicant | MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
| Contact | Mayerik, Jr |
| Correspondent | Mayerik, Jr 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 | 1986-05-20 |
| Decision Date | 1986-06-06 |