The following data is part of a premarket notification filed by Microaire Advanced Surgical Products with the FDA for Blades, Whiskers, Trimmers, Cutters, And Burs.
| Device ID | K912108 |
| 510k Number | K912108 |
| Device Name: | BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS |
| Classification | Arthroscope |
| Applicant | MICROAIRE ADVANCED SURGICAL PRODUCTS 24907 AVENUE TIBBETTS UNIT A Valencia, CA 91355 |
| Contact | Siddharth Desai |
| Correspondent | Siddharth Desai MICROAIRE ADVANCED SURGICAL PRODUCTS 24907 AVENUE TIBBETTS UNIT A Valencia, CA 91355 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-07-02 |