Device Classification Name |
barrier, animal source, intraoral
|
510(k) Number |
K192612 |
Device Name |
Kerecis Gingiva Graft |
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 |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 09/20/2019 |
Decision Date | 11/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|