The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire High Speed Drill (2910-000).
| Device ID | K894606 |
| 510k Number | K894606 |
| Device Name: | MICRO-AIRE HIGH SPEED DRILL (2910-000) |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Siddharth Desai |
| Correspondent | Siddharth Desai MICRO-AIRE SURGICAL INSTRUMENTS, INC. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-10-13 |