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 |