Device Classification Name |
Bone Grafting Material, Animal Source
|
510(k) Number |
K120601 |
Device Name |
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O |
Applicant |
GEISTLICH PHARMA AG |
555 TWELFTH STREET, NW |
WASHINGTON,
DC
20004 -1206
|
|
Applicant Contact |
DANIEL A KRACOV |
Correspondent |
GEISTLICH PHARMA AG |
555 TWELFTH STREET, NW |
WASHINGTON,
DC
20004 -1206
|
|
Correspondent Contact |
DANIEL A KRACOV |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 02/28/2012 |
Decision Date | 05/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|