PREVENA INCISION MANAGEMENT SYSTEM

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 Incision Management System.

Pre-market Notification Details

Device IDK100821
510k NumberK100821
Device Name:PREVENA INCISION MANAGEMENT SYSTEM
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant KCI USA, INC. 6203 FARINON DR. San Antonio,  TX  78249
ContactMargaret Marsh
CorrespondentMargaret Marsh
KCI USA, INC. 6203 FARINON DR. San Antonio,  TX  78249
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-23
Decision Date2010-06-11
Summary:summary

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