PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)

Negative Pressure Wound Therapy Powered Suction Pump

KCI USA, Inc.

The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Prevena Plus Incision Management System (no Ag); Prevena Plus Duo Incision Management System (no Ag).

Pre-market Notification Details

Device IDK190697
501k NumberK190697
Device Name:PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant KCI USA, Inc. 6203 Farinon Drive San Antonio,  TX  78249
ContactPatricia Lopez
CorrespondentPatricia Lopez
KCI USA, Inc. 6203 Farinon Drive San Antonio,  TX  78249
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-18
Decision Date2019-11-22

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