Device Classification Name |
Bone Grafting Material, Human Source
|
510(k) Number |
K040501 |
Device Name |
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX |
Applicant |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET |
EDISON,
NJ
08837
|
|
Applicant Contact |
KAREN HARDWICK |
Correspondent |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET |
EDISON,
NJ
08837
|
|
Correspondent Contact |
KAREN HARDWICK |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 02/26/2004 |
Decision Date | 04/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|