Device Classification Name |
barrier, animal source, intraoral
|
510(k) Number |
K012423 |
Device Name |
MUCOGRAFT |
Applicant |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
1050 CONNECTICUT AVE. NW |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
PETER S REICHERTZ |
Correspondent |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
1050 CONNECTICUT AVE. NW |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
PETER S REICHERTZ |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 07/30/2001 |
Decision Date | 01/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|