Device Classification Name |
Endoscope, Neurological
|
510(k) Number |
K043128 |
Device Name |
OLYMPUS ENDOARM |
Applicant |
OLYMPUS CORPORATION |
TWO CORPORATE CENTER DRIVE |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
TINA STEFFANIE-OAK |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NEIL E DEVINE |
Regulation Number | 882.1480
|
Classification Product Code |
|
Date Received | 11/12/2004 |
Decision Date | 12/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|