Device Classification Name |
bone grafting material, synthetic
|
510(k) Number |
K861084 |
Device Name |
OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH |
Applicant |
COORS BIOMEDICAL CO. |
12860 WEST CEDAR DR. |
SUITE 210 |
LAKEWOOD,
CO
80228
|
|
Applicant Contact |
MARY L ARMSTRONG |
Correspondent |
COORS BIOMEDICAL CO. |
12860 WEST CEDAR DR. |
SUITE 210 |
LAKEWOOD,
CO
80228
|
|
Correspondent Contact |
MARY L ARMSTRONG |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 03/21/1986 |
Decision Date | 04/30/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|