Device Classification Name |
stimulator, nerve
|
510(k) Number |
K092729 |
Device Name |
BAXANO NEURO CHECK DEVICE |
Applicant |
BAXANO, INC. |
1171 BARROILHET AVENUE |
HILLSBOROUGH,
CA
94010 -6577
|
|
Applicant Contact |
CINDY DOMECUS |
Correspondent |
BAXANO, INC. |
1171 BARROILHET AVENUE |
HILLSBOROUGH,
CA
94010 -6577
|
|
Correspondent Contact |
CINDY DOMECUS |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 09/04/2009 |
Decision Date | 10/02/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|