The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Replacement Drill Burs.
| Device ID | K820281 |
| 510k Number | K820281 |
| Device Name: | MICRO-AIRE REPLACEMENT DRILL BURS |
| Classification | Bur, Surgical, General & Plastic Surgery |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-02 |
| Decision Date | 1982-02-23 |