The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Micro-aire Model 2050e/elec Handpiece/trottleless.
| Device ID | K913266 |
| 510k Number | K913266 |
| Device Name: | MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Moe Khrosravi |
| Correspondent | Moe Khrosravi MICRO SURGICAL INSTRUMENTS CORP. 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 | 1991-07-23 |
| Decision Date | 1991-10-21 |