The following data is part of a premarket notification filed by Midway Medical, Llc. with the FDA for Plexus Scd110 Sequential Compression Device Sleeve.
| Device ID | K190975 |
| 510k Number | K190975 |
| Device Name: | Plexus SCD110 Sequential Compression Device Sleeve |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Midway Medical, LLC. 3004 Gill Street Bloomington, IL 61704 |
| Contact | Jim Tobin |
| Correspondent | Jim Tobin Midway Medical, LLC. 3004 Gill Street Bloomington, IL 61704 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2019-07-22 |
| Summary: | summary |