Avance Y-Connector S

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 Y-connector S.

Pre-market Notification Details

Device IDK151872
510k NumberK151872
Device Name:Avance Y-Connector S
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY, SUITE 500 Norcross,  GA  30092
ContactAngela Bunn
CorrespondentAngela Bunn
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 Received2015-07-09
Decision Date2015-11-02
Summary:summary

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