AVANCE FOAM DRESSING KITS

Negative Pressure Wound Therapy Powered Suction Pump

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 Avance Foam Dressing Kits.

Pre-market Notification Details

Device IDK141847
510k NumberK141847
Device Name:AVANCE FOAM DRESSING KITS
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
ContactAngela L Bunn, Rac
CorrespondentAngela L Bunn, Rac
MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-09
Decision Date2015-03-26
Summary:summary

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