The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Generic Burs & Drills.
| Device ID | K850497 |
| 510k Number | K850497 |
| Device Name: | MICRO-AIRE GENERIC BURS & DRILLS |
| Classification | Bur, Surgical, General & Plastic Surgery |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
| Contact | Gerald Brooks |
| Correspondent | Gerald Brooks MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
| Product Code | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-08 |
| Decision Date | 1985-03-01 |