Invia White Foam NPWT

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 White Foam Npwt.

Pre-market Notification Details

Device IDK180415
510k NumberK180415
Device Name:Invia White Foam NPWT
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Medela AG Laettichstrasse 4b Baar Zug,  CH Ch-6341
ContactGeorges Hakim
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 Received2018-02-15
Decision Date2018-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07612367057509 K180415 000
07612367057493 K180415 000

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