Device Classification Name |
Dilator, Catheter, Ureteral
|
510(k) Number |
K905375 |
Device Name |
ACCENT DG BALLOON URETERAL DILATOR SET |
Applicant |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 227 |
SPENCER,
IN
47460
|
|
Applicant Contact |
MICHELLE YOUNG |
Correspondent |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 227 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
MICHELLE YOUNG |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 11/30/1990 |
Decision Date | 04/12/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|