Device Classification Name |
Rongeur, Manual
|
510(k) Number |
K131851 |
Device Name |
OSTEOMED NEURO RONGEUR |
Applicant |
OSTEOMED |
3885 ARAPAHO ROAD |
ADDISON,
TX
75001
|
|
Applicant Contact |
PIEDAD PENA, M.S. |
Correspondent |
OSTEOMED |
3885 ARAPAHO ROAD |
ADDISON,
TX
75001
|
|
Correspondent Contact |
PIEDAD PENA, M.S. |
Regulation Number | 882.4840
|
Classification Product Code |
|
Date Received | 06/21/2013 |
Decision Date | 12/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|