The following data is part of a premarket notification filed by Microaire Surgical Instruments, Inc. with the FDA for Microaire 1000e System.
| Device ID | K014060 |
| 510k Number | K014060 |
| Device Name: | MICROAIRE 1000E SYSTEM |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville, VA 22911 |
| Contact | Carl Angles |
| Correspondent | Carl Angles MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville, VA 22911 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-10 |
| Decision Date | 2002-03-05 |
| Summary: | summary |