K801737 is an FDA 510(k) clearance for the STERNUM SAW. This device is classified as a Saw, Pneumatically Powered (Class I - General Controls, product code KFK).
Submitted by Amsco Co. (Walker, US). The FDA issued a Cleared decision on August 20, 1980, 26 days after receiving the submission on July 25, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K801737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1980 |
| Decision Date | August 20, 1980 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KFK — Saw, Pneumatically Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |