Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K935094 |
FOIA Releasable 510(k) |
K935094
|
Device Name |
BALLOON DILATION CATHETER |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & |
5951 GRASSY CREEK BLVD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
PAULA A JOYCE |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & |
5951 GRASSY CREEK BLVD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
PAULA A JOYCE |
Regulation Number | 876.5010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/22/1993 |
Decision Date | 01/24/1995 |
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
|
|
|