Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves

Sleeve, Limb, Compressible

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Reprocessed Kendall Scd Express Compression Sleeves, Reprocessed Kendall Scd Comfort Compression Sleeves.

Pre-market Notification Details

Device IDK163620
510k NumberK163620
Device Name:Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
ClassificationSleeve, Limb, Compressible
Applicant Covidien 15 Hampshire Stree Mansfield,  MA  02048
ContactNicole Genco
CorrespondentNicole Genco
Covidien 15 Hampshire Stree Mansfield,  MA  02048
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-22
Decision Date2017-01-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.