K894301 is an FDA 510(k) clearance for the MICRO-AIRE STERNUM SAW 4800. This device is classified as a Saw, Pneumatically Powered (Class I - General Controls, product code KFK).
Submitted by Micro Surgical Instruments Corp. (Valencia, US). The FDA issued a Cleared decision on August 3, 1989, 41 days after receiving the submission on June 23, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K894301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1989 |
| Decision Date | August 03, 1989 |
| Days to Decision | 41 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 |