Reprocessed Kendall SCD Express Foot Cuff

Sleeve, Limb, Compressible

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Reprocessed Kendall Scd Express Foot Cuff.

Pre-market Notification Details

Device IDK163055
510k NumberK163055
Device Name:Reprocessed Kendall SCD Express Foot Cuff
ClassificationSleeve, Limb, Compressible
Applicant COVIDIEN 15 HAMPSHIRE STREET Mansfield,  MA  02048
ContactJennifer Sullivan
CorrespondentJennifer Sullivan
COVIDIEN 15 HAMPSHIRE STREET Mansfield,  MA  02048
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-01
Decision Date2016-12-23
Summary:summary

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