The following data is part of a premarket notification filed by Microaire Surgical Instruments, Inc. with the FDA for Microaire Power Aspiration Device Pad System.
| Device ID | K973268 |
| 510k Number | K973268 |
| Device Name: | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville, VA 22911 |
| Contact | Ccarl Angles |
| Correspondent | Ccarl Angles MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville, VA 22911 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-29 |
| Decision Date | 1997-11-26 |
| Summary: | summary |