Device Classification Name |
bone grafting material, animal source
|
510(k) Number |
K112575 |
Device Name |
GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO |
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 |
|
Subsequent Product Code |
|
Date Received | 09/06/2011 |
Decision Date | 12/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|