Device Classification Name |
bone grafting material, synthetic
|
510(k) Number |
K053387 |
Device Name |
PERIOGLAS BONE GRAFT PARTICULATE |
Applicant |
NovaBone Products, LLC |
13709 PROGRESS BLVD., #33 |
ALACHUA,
FL
32615
|
|
Applicant Contact |
DAVID M GAISSER |
Correspondent |
NovaBone Products, LLC |
13709 PROGRESS BLVD., #33 |
ALACHUA,
FL
32615
|
|
Correspondent Contact |
DAVID M GAISSER |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 12/05/2005 |
Decision Date | 02/14/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|