Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K902099 |
Device Name |
WILSON-COOK VARICES TAMPONADE BALLOON CUFF |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & |
5951 GRASSY CREEK BLVD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & |
5951 GRASSY CREEK BLVD. |
WINSTON-SALEM,
NC
27105
|
|
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 05/08/1990 |
Decision Date | 11/07/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|