Device Classification Name |
Motor, Drill, Electric
|
510(k) Number |
K083112 |
Device Name |
PRIMADO |
Applicant |
NAKANISHI, INC. |
1425 K STREET, N.W. |
SUITE 1100 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
KEITH A BARRITT |
Correspondent |
NAKANISHI, INC. |
1425 K STREET, N.W. |
SUITE 1100 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
KEITH A BARRITT |
Regulation Number | 882.4360
|
Classification Product Code |
|
Date Received | 10/21/2008 |
Decision Date | 04/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|