The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Micro-aire Model Number: Mk-426.
| Device ID | K905097 |
| 510k Number | K905097 |
| Device Name: | MICRO-AIRE MODEL NUMBER: MK-426 |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Moe Khosravi |
| Correspondent | Moe Khosravi MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-13 |
| Decision Date | 1990-12-21 |