ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT

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 Activac Therapy Unit And Infovac Therapy Unit, Vac Ats Therapy Unit And Vac Freedom Therapy Unit, Vac Via Therapy Unit.

Pre-market Notification Details

Device IDK120033
510k NumberK120033
Device Name:ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant KCI USA, INC. 6203 FARINON DR. San Antonio,  TX  78249
ContactShannon Scott
CorrespondentShannon Scott
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 Received2012-01-04
Decision Date2012-05-31
Summary:summary

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