Device Classification Name |
Bone Grafting Material, Human Source
|
510(k) Number |
K080462 |
Device Name |
PROGENIX DBM PUTTY |
Applicant |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
MICHELLE OBENAUER |
Correspondent |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
MICHELLE OBENAUER |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 02/20/2008 |
Decision Date | 05/13/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|