V.A.C.ULTA Negative Pressure Wound Therapy System

Negative Pressure Wound Therapy Powered Suction Pump

KCI, A Part Of 3M Health Care Business Group

The following data is part of a premarket notification filed by Kci, A Part Of 3m Health Care Business Group with the FDA for V.a.c.ulta Negative Pressure Wound Therapy System.

Pre-market Notification Details

Device IDK203316
510k NumberK203316
Device Name:V.A.C.ULTA Negative Pressure Wound Therapy System
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant KCI, A Part Of 3M Health Care Business Group 6203 Farinon Drive San Antonio,  TX  78249
ContactMargaret Marsh
CorrespondentMargaret Marsh
KCI, A Part Of 3M Health Care Business Group 6203 Farinon Drive San Antonio,  TX  78249
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-10
Decision Date2021-10-27

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