AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM

Negative Pressure Wound Therapy Powered Suction Pump

MOLNLYCKE HEALTH CARE

The following data is part of a premarket notification filed by Molnlycke Health Care with the FDA for Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (small, Medium, Large) Avance Transparent Film Avance Foam.

Pre-market Notification Details

Device IDK122132
510k NumberK122132
Device Name:AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
ContactAngela L Bunn
CorrespondentAngela L Bunn
MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-18
Decision Date2013-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07323190023226 K122132 000

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