Device Classification Name |
screw, fixation, intraosseous
|
510(k) Number |
K130682 |
Device Name |
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT |
Applicant |
HAGER & MEISINGER GMBH |
HANSEMANNSTRASSE 10 |
NEUSS,
DE
D-41468
|
|
Applicant Contact |
WIEBKE STOLTEN |
Correspondent |
HAGER & MEISINGER GMBH |
HANSEMANNSTRASSE 10 |
NEUSS,
DE
D-41468
|
|
Correspondent Contact |
WIEBKE STOLTEN |
Regulation Number | 872.4880
|
Classification Product Code |
|
Date Received | 03/13/2013 |
Decision Date | 08/13/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|