GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING

Dressing, Wound, Drug

HEMCON MEDICAL TECHNOLOGIES EUROPE LTD

The following data is part of a premarket notification filed by Hemcon Medical Technologies Europe Ltd with the FDA for Guardiva Antimicrobial Haemstatic Iv Dressing.

Pre-market Notification Details

Device IDK121485
510k NumberK121485
Device Name:GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
ClassificationDressing, Wound, Drug
Applicant HEMCON MEDICAL TECHNOLOGIES EUROPE LTD 10575 SW CASCADE AVENUE SUITE 130 Portland,  OR  97223 -4363
ContactBarbara Mcgrath
CorrespondentBarbara Mcgrath
HEMCON MEDICAL TECHNOLOGIES EUROPE LTD 10575 SW CASCADE AVENUE SUITE 130 Portland,  OR  97223 -4363
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-05-18
Decision Date2012-08-21
Summary:summary

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