Avance Gauze 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 Gauze Dressing Kits.

Pre-market Notification Details

Device IDK161948
510k NumberK161948
Device Name:Avance Gauze Dressing Kits
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY, SUITE 500 Norcross,  GA  30092
ContactMegan Bevill
CorrespondentMegan Bevill
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 ProductYes
Date Received2016-07-15
Decision Date2016-11-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.