Device Classification Name |
bone grafting material, animal source
|
510(k) Number |
K170245 |
Device Name |
DSM Biomedical Dental Bone Graft |
Applicant |
Kensey Nash Corporation dba DSM Biomedical |
735 Pennsylvania Drive |
Exton,
PA
19341
|
|
Applicant Contact |
Susan Pileggi |
Correspondent |
Kensey Nash Corporation dba DSM Biomedical |
735 Pennsylvania Drive |
Exton,
PA
19341
|
|
Correspondent Contact |
Susan Pileggi |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 01/26/2017 |
Decision Date | 05/16/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|