Device Classification Name |
Dilator, Catheter, Ureteral
|
510(k) Number |
K841940 |
Device Name |
VAN-TEC URETERAL DILATION BALLOON CATH |
Applicant |
VAN-TEC, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
VAN-TEC, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 05/11/1984 |
Decision Date | 08/03/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|