K862474 is an FDA 510(k) clearance for the HALL STERNUM SAW. This device is classified as a Blade, Saw, Surgical, Cardiovascular (Class I - General Controls, product code DWH).
Submitted by Hall Surgical, Division of Zimmer, Inc. (`Anta Barbara, US). The FDA issued a Cleared decision on July 17, 1986, 17 days after receiving the submission on June 30, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K862474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1986 |
| Decision Date | July 17, 1986 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | DWH — Blade, Saw, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |