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 |