ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026

Mesh, Surgical, Polymeric

KCI USA, INC.

The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Abthera Open Abdomen Dressing, Model: M8275026.

Pre-market Notification Details

Device IDK090489
510k NumberK090489
Device Name:ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
ClassificationMesh, Surgical, Polymeric
Applicant KCI USA, INC. 6203 FARINON DR. San Antonio,  TX  78249
ContactChristy H Oviatt
CorrespondentChristy H Oviatt
KCI USA, INC. 6203 FARINON DR. San Antonio,  TX  78249
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-25
Decision Date2009-05-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849554001268 K090489 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.