The following data is part of a premarket notification filed by Microaire Surgical Instruments, Inc. with the FDA for Microaire Smartdrive System.
| Device ID | K955591 |
| 510k Number | K955591 |
| Device Name: | MICROAIRE SMARTDRIVE SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville, VA 22911 |
| Contact | Mike Fard |
| Correspondent | Mike Fard MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville, VA 22911 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-07 |
| Decision Date | 1996-01-18 |