Device Classification Name |
Bone Grafting Material, Synthetic
|
510(k) Number |
K000149 |
Device Name |
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE |
Applicant |
U.S. BIOMATERIALS CORP. |
ONE PROGRESS BLVD. |
ALACHUA,
FL
32615
|
|
Applicant Contact |
ALBERT FOSMOE |
Correspondent |
U.S. BIOMATERIALS CORP. |
ONE PROGRESS BLVD. |
ALACHUA,
FL
32615
|
|
Correspondent Contact |
ALBERT FOSMOE |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 01/19/2000 |
Decision Date | 02/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|