The following data is part of a premarket notification filed by Microaire Surgical Instruments, Llc with the FDA for Lipofilter - Hospital Pack, Lipofilter - Clinic Pack.
| Device ID | K150779 |
| 510k Number | K150779 |
| Device Name: | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack |
| Classification | System, Suction, Lipoplasty |
| Applicant | MICROAIRE SURGICAL INSTRUMENTS, LLC 3590 Grand Forks Blvd Charlottesville, VA 22911 |
| Contact | Chris Spofford |
| Correspondent | Chris Spofford MICROAIRE SURGICAL INSTRUMENTS, LLC 3590 Grand Forks Blvd Charlottesville, VA 22911 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-25 |
| Decision Date | 2015-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847399015891 | K150779 | 000 |
| 00847399006486 | K150779 | 000 |