The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Osteotome System Or Bone Harvester.
| Device ID | K874503 |
| 510k Number | K874503 |
| Device Name: | MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER |
| Classification | Osteotome |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
| Contact | Siddharth Desai |
| Correspondent | Siddharth Desai MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
| Product Code | HWM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-02 |
| Decision Date | 1987-12-02 |