Device Classification Name |
stimulator, nerve
|
510(k) Number |
K090838 |
Device Name |
STIMULUS/DISSECTION INSTRUMENTS |
Applicant |
AXON SYSTEMS, INC. |
80-5 DAVIDS DRIVE |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
HOWARD BAILIN |
Correspondent |
AXON SYSTEMS, INC. |
80-5 DAVIDS DRIVE |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
HOWARD BAILIN |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 03/27/2009 |
Decision Date | 07/20/2009 |
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
|
|
|