CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL

Dressing, Wound, Drug

AVERY DENNISON BELGIE, BVBA

The following data is part of a premarket notification filed by Avery Dennison Belgie, Bvba with the FDA for Chlorashield Iv Dressing With Chg Antimicrobial.

Pre-market Notification Details

Device IDK133764
510k NumberK133764
Device Name:CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
ClassificationDressing, Wound, Drug
Applicant AVERY DENNISON BELGIE, BVBA TIEBLOKKENLAAN 1 Turnhout,  BE B-2300
ContactLisa Bartakovics
CorrespondentLisa Bartakovics
AVERY DENNISON BELGIE, BVBA TIEBLOKKENLAAN 1 Turnhout,  BE B-2300
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2013-12-11
Decision Date2014-03-13
Summary:summary

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