Avance Solo Negative Pressure Wound Therapy (NPWT) System

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 Solo Negative Pressure Wound Therapy (npwt) System.

Pre-market Notification Details

Device IDK203369
510k NumberK203369
Device Name:Avance Solo Negative Pressure Wound Therapy (NPWT) System
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Molnlycke Health Care US, LLC 5445 Triangle Parkway Suite 400 Peachtree Corners,  GA  30092
ContactMegan Bevill
CorrespondentMegan Bevill
Molnlycke Health Care US, LLC 5445 Triangle Parkway Suite 400 Peachtree Corners,  GA  30092
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-16
Decision Date2021-07-01

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