Device Classification Name |
Endoscope, Neurological
|
510(k) Number |
K955598 |
Device Name |
CLARUS SPINEPEN MODEL 2126 |
Applicant |
CLARUS MEDICAL SYSTEMS, INC. |
1000 BOONE AVENUE NORTH |
#100 |
MINNEAPOLIS,
MN
55427 -8656
|
|
Applicant Contact |
JOHN VANDEN HOEK |
Correspondent |
CLARUS MEDICAL SYSTEMS, INC. |
1000 BOONE AVENUE NORTH |
#100 |
MINNEAPOLIS,
MN
55427 -8656
|
|
Correspondent Contact |
JOHN VANDEN HOEK |
Regulation Number | 882.1480
|
Classification Product Code |
|
Date Received | 12/08/1995 |
Decision Date | 02/06/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|