Kerecis Silicone

Dressing, Wound, Collagen

Kerecis Limited

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

Pre-market Notification Details

Device IDK213231
510k NumberK213231
Device Name:Kerecis Silicone
ClassificationDressing, Wound, Collagen
Applicant Kerecis Limited Eyrargata 2 Isafjordur,  IS 400
ContactGudmundur Fertram Sigurjonsson
CorrespondentGudmundur Fertram Sigurjonsson
Kerecis Limited Eyrargata 2 Isafjordur,  IS 400
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-06-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05694310963787 K213231 000
05694310963763 K213231 000
05694310964326 K213231 000
05694310964371 K213231 000

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