Invia Abdominal Dressing Kit

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 Abdominal Dressing Kit.

Pre-market Notification Details

Device IDK182191
510k NumberK182191
Device Name:Invia Abdominal Dressing Kit
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Medela AG Laettichstrasse 4b Baar Zug,  CH Ch-6341
ContactJudith Bernardo
CorrespondentAdrienne Lenz
Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington,  DC  20005
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-13
Decision Date2019-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07612367054003 K182191 000

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