Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K903323 |
Device Name |
RESECTOSCOPE LOOPS |
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 | 876.4300
|
Classification Product Code |
|
Date Received | 07/25/1990 |
Decision Date | 10/01/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|