Plexus SCD110 Sequential Compression Device Sleeve

Sleeve, Limb, Compressible

Midway Medical, LLC.

The following data is part of a premarket notification filed by Midway Medical, Llc. with the FDA for Plexus Scd110 Sequential Compression Device Sleeve.

Pre-market Notification Details

Device IDK190975
510k NumberK190975
Device Name:Plexus SCD110 Sequential Compression Device Sleeve
ClassificationSleeve, Limb, Compressible
Applicant Midway Medical, LLC. 3004 Gill Street Bloomington,  IL  61704
ContactJim Tobin
CorrespondentJim Tobin
Midway Medical, LLC. 3004 Gill Street Bloomington,  IL  61704
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-15
Decision Date2019-07-22
Summary:summary

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