HaloGUARD Protective Disc With CHG

Dressing, Wound, Drug

ATTWILL Medical Solutions

The following data is part of a premarket notification filed by Attwill Medical Solutions with the FDA for Haloguard Protective Disc With Chg.

Pre-market Notification Details

Device IDK200641
510k NumberK200641
Device Name:HaloGUARD Protective Disc With CHG
ClassificationDressing, Wound, Drug
Applicant ATTWILL Medical Solutions 925 Development Drive Lodi,  WI  53555
ContactAttilio Di Fiore
CorrespondentAmarinder S. Gill
ATTWILL Medical Solutions 925 Development Drive Lodi,  WI  53555
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2020-03-11
Decision Date2020-09-03

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.