Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K960415 |
Device Name |
WILSON-COOK BALLOON INFLATION DEVICE |
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 | 876.5980
|
Classification Product Code |
|
Date Received | 01/29/1996 |
Decision Date | 04/26/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|