The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Replacement Saw Blades.
| Device ID | K811506 |
| 510k Number | K811506 |
| Device Name: | MICRO-AIRE REPLACEMENT SAW BLADES |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-27 |
| Decision Date | 1981-08-13 |