MARIGEN WOUND DRESSING

Dressing, Wound, Collagen

KERECIS LIMITED

The following data is part of a premarket notification filed by Kerecis Limited with the FDA for Marigen Wound Dressing.

Pre-market Notification Details

Device IDK132343
510k NumberK132343
Device Name:MARIGEN WOUND DRESSING
ClassificationDressing, Wound, Collagen
Applicant KERECIS LIMITED EYRARGATA 2 Isafijordur,  IS 400
ContactGudmundur F Sigurjonsson
CorrespondentGudmundur F Sigurjonsson
KERECIS LIMITED EYRARGATA 2 Isafijordur,  IS 400
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-30
Decision Date2013-10-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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