NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING

Dressing, Wound, Drug

HEMOSTASIS, LLC

The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Nexstat Plus And Nexfoam Plus Topical Hemostat Dressing.

Pre-market Notification Details

Device IDK122886
510k NumberK122886
Device Name:NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
ClassificationDressing, Wound, Drug
Applicant HEMOSTASIS, LLC 4486 TIMBERLINE CT Vadnais Hts,  MN  55127
ContactBernard Horwath
CorrespondentBernard Horwath
HEMOSTASIS, LLC 4486 TIMBERLINE CT Vadnais Hts,  MN  55127
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-20
Decision Date2012-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858439001408 K122886 000
00858439001293 K122886 000

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