ACTICOAT FOAM DRESSING

Dressing, Wound, Drug

WESTAIM BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Westaim Biomedical, Inc. with the FDA for Acticoat Foam Dressing.

Pre-market Notification Details

Device IDK000051
510k NumberK000051
Device Name:ACTICOAT FOAM DRESSING
ClassificationDressing, Wound, Drug
Applicant WESTAIM BIOMEDICAL, INC. ONE HAMPTON RD. SUITE 302 Exeter,  NH  03833
ContactSteve Chartier
CorrespondentSteve Chartier
WESTAIM BIOMEDICAL, INC. ONE HAMPTON RD. SUITE 302 Exeter,  NH  03833
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-07
Decision Date2000-04-05

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