Kerecis Reconstruct

Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

Kerecis Limited

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

Pre-market Notification Details

Device IDK202430
510k NumberK202430
Device Name:Kerecis Reconstruct
ClassificationMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Applicant Kerecis Limited Eyrargata 2 – PO Box 151 Isafjordur,  IS 400
ContactGudmundur Fertram Sigurjonsson
CorrespondentGudmundur Fertram Sigurjonsson
Kerecis Limited Eyrargata 2 – PO Box 151 Isafjordur,  IS 400
Product CodeOXH  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-25
Decision Date2021-05-02

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