The following data is part of a premarket notification filed by Microaire Surgical Instruments with the FDA for Pal Single-use Cannulas.
| Device ID | K192694 |
| 510k Number | K192694 |
| Device Name: | PAL Single-Use Cannulas |
| Classification | System, Suction, Lipoplasty |
| Applicant | MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA 22911 |
| Contact | Glenn Gerstenfeld |
| Correspondent | Diane Sudduth Barile & Associates, Inc. PO Box 5199 Clinton, NJ 08809 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-05-14 |