Device Classification Name |
biopsy needle
|
510(k) Number |
K943304 |
Device Name |
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY |
Applicant |
OLYMPUS AMERICA, INC. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042 -1179
|
|
Applicant Contact |
BARRY E SANDS |
Correspondent |
OLYMPUS AMERICA, INC. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042 -1179
|
|
Correspondent Contact |
BARRY E SANDS |
Regulation Number | 876.1075
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/08/1994 |
Decision Date | 12/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|