BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET

System, Thermal Regulating

MOLNLYCKE HEALTH CARE US, LLC

The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Barrier Easywarm Active Self-warming Blanket.

Pre-market Notification Details

Device IDK132048
510k NumberK132048
Device Name:BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
ClassificationSystem, Thermal Regulating
Applicant MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
ContactCurtis D Truesdale
CorrespondentCurtis D Truesdale
MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-02
Decision Date2013-11-06
Summary:summary

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