EXCELARREST FOAM

Dressing, Wound, Drug

HEMOSTASIS, LLC

The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Excelarrest Foam.

Pre-market Notification Details

Device IDK072900
510k NumberK072900
Device Name:EXCELARREST FOAM
ClassificationDressing, Wound, Drug
Applicant HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul,  MN  55110
ContactKeith Roberts
CorrespondentKeith Roberts
HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul,  MN  55110
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-11
Decision Date2007-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858439001705 K072900 000

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