Hydroven 12, Hydroven 12 Garments

Sleeve, Limb, Compressible

HUNTLEIGH HEALTHCARE LTD

The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd with the FDA for Hydroven 12, Hydroven 12 Garments.

Pre-market Notification Details

Device IDK152228
510k NumberK152228
Device Name:Hydroven 12, Hydroven 12 Garments
ClassificationSleeve, Limb, Compressible
Applicant HUNTLEIGH HEALTHCARE LTD 35 PORTMANMOOR ROAD Cardiff,  GB Cf24 5hn
ContactGreg Baily
CorrespondentGreg Baily
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 Received2015-08-07
Decision Date2016-04-04
Summary:summary

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