The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Micro-aire Model 2060.
| Device ID | K913369 |
| 510k Number | K913369 |
| Device Name: | MICRO-AIRE MODEL 2060 |
| 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 | 1991-07-29 |
| Decision Date | 1991-11-01 |