SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN

Dressing, Wound And Burn, Occlusive

EUROMED, INC.

The following data is part of a premarket notification filed by Euromed, Inc. with the FDA for Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin.

Pre-market Notification Details

Device IDK983249
510k NumberK983249
Device Name:SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN
ClassificationDressing, Wound And Burn, Occlusive
Applicant EUROMED, INC. 49 PLAIN ST. North Attleboro,  MA  02760
ContactMary Mcnamara-cullinane
CorrespondentMary Mcnamara-cullinane
EUROMED, INC. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeMGP  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-16
Decision Date1998-11-25
Summary:summary

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