Device Classification Name |
bone grafting material, synthetic
|
510(k) Number |
K040783 |
Device Name |
FOUNDATION |
Applicant |
TERUMO CORP. |
1425 K STREET N.W. |
SUITE 1100 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
KEITH A BARRITT, ESQ. |
Correspondent |
TERUMO CORP. |
1425 K STREET N.W. |
SUITE 1100 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
KEITH A BARRITT, ESQ. |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 03/26/2004 |
Decision Date | 10/13/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|