WoundExpress

Sleeve, Limb, Compressible

Huntleigh Healthcare Ltd

The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd with the FDA for Woundexpress.

Pre-market Notification Details

Device IDK211200
510k NumberK211200
Device Name:WoundExpress
ClassificationSleeve, Limb, Compressible
Applicant Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff,  GB Cf24 5hn
ContactSteve Monks
CorrespondentSteve Monks
Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff,  GB Cf24 5hn
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-22
Decision Date2021-09-03

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