ACTIV.A.C. Negative Pressure Wound Therapy 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 Activ.a.c. Negative Pressure Wound Therapy System.

Pre-market Notification Details

Device IDK201571
510k NumberK201571
Device Name:ACTIV.A.C. Negative Pressure Wound Therapy System
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant KCI USA, Inc 6203 Farinon Drive San Antonio,  TX  78249
ContactJesus Valencia
CorrespondentJesus Valencia
KCI USA, Inc 6203 Farinon Drive San Antonio,  TX  78249
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-11
Decision Date2020-07-08

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