K872389 is an FDA 510(k) clearance for the PRECISION SCREW DRIVER SET. This device is classified as a Screwdriver (Class I - General Controls, product code HXX).
Submitted by Med-Tool, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 15, 1987, 26 days after receiving the submission on June 19, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K872389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1987 |
| Decision Date | July 15, 1987 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HXX — Screwdriver |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |