MEDELA INVIA WOUND THERAPY

Negative Pressure Wound Therapy Powered Suction Pump

MEDELA AG

The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Invia Wound Therapy.

Pre-market Notification Details

Device IDK080357
510k NumberK080357
Device Name:MEDELA INVIA WOUND THERAPY
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant MEDELA AG LAETTICHSTRASSE 4B Baar, Zug,  CH Ch-6341
ContactBruno Gretler
CorrespondentBruno Gretler
MEDELA AG LAETTICHSTRASSE 4B Baar, Zug,  CH Ch-6341
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-11
Decision Date2008-07-24
Summary:summary

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