Device Classification Name |
wound dressing with animal-derived material(s)
|
510(k) Number |
K190528 |
Device Name |
MariGen Wound Extra |
Applicant |
Kerecis Limited |
Eyrargata 2 |
Isafjordur,
IS
400
|
|
Applicant Contact |
Gudmundur Fertram Sigurjonsson |
Correspondent |
Kerecis Limited |
Eyrargata 2 |
Isafjordur,
IS
400
|
|
Correspondent Contact |
Gudmundur Fertram Sigurjonsson |
Classification Product Code |
|
Date Received | 03/04/2019 |
Decision Date | 07/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|