K874503 is an FDA 510(k) clearance for the MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER. This device is classified as a Osteotome (Class I - General Controls, product code HWM).
Submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on December 2, 1987, 30 days after receiving the submission on November 2, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K874503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1987 |
| Decision Date | December 02, 1987 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HWM — Osteotome |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |