The following data is part of a premarket notification filed by Microaire Surgical Instruments, Llc with the FDA for Pal Infiltration System.
| Device ID | K220318 |
| 510k Number | K220318 |
| Device Name: | PAL Infiltration System |
| Classification | System, Suction, Lipoplasty For Removal |
| Applicant | MicroAire Surgical Instruments, LLC 3590 Grand Forks Blvd Charlottesville, VA 22911 |
| Contact | Glenn Gerstenfeld |
| Correspondent | Glenn Gerstenfeld MicroAire Surgical Instruments, LLC 3590 Grand Forks Blvd Charlottesville, VA 22911 |
| Product Code | QPB |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-03 |
| Decision Date | 2022-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847399017222 | K220318 | 000 |
| 00847399016669 | K220318 | 000 |
| 00847399016676 | K220318 | 000 |
| 00847399016706 | K220318 | 000 |
| 00847399016713 | K220318 | 000 |
| 00847399016720 | K220318 | 000 |
| 00847399016737 | K220318 | 000 |
| 00847399016744 | K220318 | 000 |
| 00847399016751 | K220318 | 000 |
| 00847399016768 | K220318 | 000 |
| 00847399016775 | K220318 | 000 |
| 00847399016782 | K220318 | 000 |
| 10847399016796 | K220318 | 000 |
| 00847399017178 | K220318 | 000 |
| 00847399017185 | K220318 | 000 |
| 00847399017192 | K220318 | 000 |
| 00847399017208 | K220318 | 000 |
| 00847399017215 | K220318 | 000 |
| 00847399016645 | K220318 | 000 |