Device Classification Name |
Rongeur, Manual
|
510(k) Number |
K113073 |
Device Name |
IO-TOME DEVICE |
Applicant |
BAXANO, INC. |
655 RIVER OAKS PKWY |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
EDWARD J SINCLAIR |
Correspondent |
BAXANO, INC. |
655 RIVER OAKS PKWY |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
EDWARD J SINCLAIR |
Regulation Number | 882.4840
|
Classification Product Code |
|
Date Received | 10/17/2011 |
Decision Date | 07/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|