Device Classification Name |
electrode, electrosurgical, active, urological
|
510(k) Number |
K931763 |
Device Name |
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS |
Applicant |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
BARRY E SANDS |
Correspondent |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
BARRY E SANDS |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/08/1993 |
Decision Date | 08/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|