Device Classification Name |
Bone Grafting Material, Synthetic
|
510(k) Number |
K000633 |
Device Name |
SYNTHETIC GLASS BONE GRAFT MATERIAL |
Applicant |
BLUE SKY BIO |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
RITA GIEBEL |
Correspondent |
BLUE SKY BIO |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
RITA GIEBEL |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 02/25/2000 |
Decision Date | 05/25/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|