Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K870697 |
Device Name |
VAN-TEC ONE STEP URETERAL DILATATION CATHETER |
Applicant |
VAN-TEC, INC. |
P.O. BOX 26 |
SPENCER,
IN
47460
|
|
Applicant Contact |
JAMES F VANCE |
Correspondent |
VAN-TEC, INC. |
P.O. BOX 26 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
JAMES F VANCE |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 02/19/1987 |
Decision Date | 03/10/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|