The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Cement Removal Tools.
| Device ID | K880324 |
| 510k Number | K880324 |
| Device Name: | MICRO-AIRE CEMENT REMOVAL TOOLS |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| 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 | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-02-17 |