INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM

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 Invia Endure Negative Pressure Wound Therapy System.

Pre-market Notification Details

Device IDK141926
510k NumberK141926
Device Name:INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant MEDELA AG W324S3649 COUNTY ROAD E Dousman,  WI  53118
ContactAdrienne Lenz
CorrespondentAdrienne Lenz
MEDELA AG W324S3649 COUNTY ROAD E Dousman,  WI  53118
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-16
Decision Date2014-12-19
Summary:summary

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