K840978 is an FDA 510(k) clearance for the TOGGLE LOCKING PLIER. This device is classified as a Pliers, Surgical (Class I — General Controls, product code HTC).
Submitted by Med-Tool, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984, 50 days after receiving the submission on March 6, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K840978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1984 |
| Decision Date | April 25, 1984 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HTC — Pliers, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |