Device Classification Name |
Bone Grafting Material, Animal Source
|
510(k) Number |
K202183 |
Device Name |
Porcine Mineral Collagen Composite |
Applicant |
Collagen Matrix, Inc. |
15 Thornton Road |
Oakland,
NJ
07436
|
|
Applicant Contact |
Gloria Zuclich |
Correspondent |
Collagen Matrix, Inc. |
15 Thornton Road |
Oakland,
NJ
07436
|
|
Correspondent Contact |
Gloria Zuclich |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 08/04/2020 |
Decision Date | 04/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|