Device Classification Name |
Bone Grafting Material, Animal Source
|
510(k) Number |
K151209 |
Device Name |
InterOss |
Applicant |
SigmaGraft, Inc |
335 N. Puente St. |
Unit A |
Brea,
CA
92821
|
|
Applicant Contact |
Megan Holden |
Correspondent |
SigmaGraft, Inc |
335 N. Puente St. |
Unit A |
Brea,
CA
92821
|
|
Correspondent Contact |
Megan Holden |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 05/06/2015 |
Decision Date | 11/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|