Sorbact Wound Dressing-Ribbon Gauze

Dressing, Wound, Drug

ABIGO Medical AB

The following data is part of a premarket notification filed by Abigo Medical Ab with the FDA for Sorbact Wound Dressing-ribbon Gauze.

Pre-market Notification Details

Device IDK171225
510k NumberK171225
Device Name:Sorbact Wound Dressing-Ribbon Gauze
ClassificationDressing, Wound, Drug
Applicant ABIGO Medical AB Ekonomivagen 5 Askim,  SE Se-436 33
ContactAnnica Corbe
CorrespondentDeborah Lavoie Grayeski
M Squared Associates, Inc. 575 8th Avenue, Suite 1212 New York,  NY  10018
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-26
Decision Date2017-08-21
Summary:summary

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