Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K851144 |
Device Name |
URETERAL DILATION SET |
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 | 03/21/1985 |
Decision Date | 04/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|