Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K912331 |
Device Name |
URS-HYDRO-DILATOR MODEL NUMBER 2164.00 |
Applicant |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
7046 LYNDON AVE. |
ROSEMONT,
IL
60018
|
|
Applicant Contact |
ROBERT L CASARSA |
Correspondent |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
7046 LYNDON AVE. |
ROSEMONT,
IL
60018
|
|
Correspondent Contact |
ROBERT L CASARSA |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 05/24/1991 |
Decision Date | 10/30/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|