Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K880748 |
Device Name |
BALL TIP FULGURATING ELECTRODE, 3 FRENCH |
Applicant |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 227 |
SPENCER,
IN
47460
|
|
Applicant Contact |
D ROEMER |
Correspondent |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 227 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
D ROEMER |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 02/24/1988 |
Decision Date | 08/04/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|