Device Classification Name |
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
|
510(k) Number |
K953951 |
Device Name |
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
PAULA JOYCE |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
PAULA JOYCE |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 08/22/1995 |
Decision Date | 09/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|