Device Classification Name |
Mediastinoscope, Surgical
|
510(k) Number |
K912362 |
Device Name |
OES THORACOSCOPE SYSTEM |
Applicant |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
DANIEL J DILLON |
Correspondent |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
DANIEL J DILLON |
Regulation Number | 874.4720
|
Classification Product Code |
|
Date Received | 05/29/1991 |
Decision Date | 10/24/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|