VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100

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 Vac Therapy System, Models 340000, M8259999, 320000, M8259968 And 320100.

Pre-market Notification Details

Device IDK091585
510k NumberK091585
Device Name:VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
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 Received2009-06-02
Decision Date2009-12-29
Summary:summary

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