The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Powered Micro-surgery Instruments.
| Device ID | K900033 |
| 510k Number | K900033 |
| Device Name: | MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS |
| Classification | Motor, Surgical Instrument, Ac-powered |
| 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 | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-02 |
| Decision Date | 1990-02-13 |