Device Classification Name |
Stimulator, Nerve
|
510(k) Number |
K112709 |
Device Name |
STIMULATION/DISSECTION INSTRUMENTS |
Applicant |
NUVASIVE, INCORPORATED |
7475 LUSK BOULEVARD |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
Elias Ketchum |
Correspondent |
NUVASIVE, INCORPORATED |
7475 LUSK BOULEVARD |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
Elias Ketchum |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 09/19/2011 |
Decision Date | 02/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|