K831714 is an FDA 510(k) clearance for the MICRO-AIRE REPLACEMENT SURG. SAW BLADE. This device is classified as a Blade, Saw, General & Plastic Surgery, Surgical (Class I - General Controls, product code GFA).
Submitted by Micro-Aire Surgical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983, 41 days after receiving the submission on May 27, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K831714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 1983 |
| Decision Date | July 07, 1983 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GFA — Blade, Saw, General & Plastic Surgery, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |