K894438 is an FDA 510(k) clearance for the MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS. This device is classified as a Bur, Surgical, General & Plastic Surgery (Class I - General Controls, product code GFF).
Submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on August 21, 1989, 35 days after receiving the submission on July 17, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K894438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1989 |
| Decision Date | August 21, 1989 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GFF — Bur, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |