Device Classification Name |
Endoscope, Neurological
|
510(k) Number |
K953554 |
Device Name |
NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES |
Applicant |
NOBLES-LAI ENGINEERING, INC. |
17080 NEWHOPE ST. |
FOUNTAIN VALLEY,
CA
92708
|
|
Applicant Contact |
NANCY E SHADFORTH |
Correspondent |
NOBLES-LAI ENGINEERING, INC. |
17080 NEWHOPE ST. |
FOUNTAIN VALLEY,
CA
92708
|
|
Correspondent Contact |
NANCY E SHADFORTH |
Regulation Number | 882.1480
|
Classification Product Code |
|
Date Received | 07/28/1995 |
Decision Date | 10/18/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|