Device Classification Name |
Dilator, Esophageal
|
510(k) Number |
K933845 |
Device Name |
WILSON-COOK BALLOON INFLATION DEVICE |
Applicant |
WILSON-COOK MEDICAL, INC. |
P.O.BOX 2402 |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
NEAL E FEARNOT |
Correspondent |
WILSON-COOK MEDICAL, INC. |
P.O.BOX 2402 |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
NEAL E FEARNOT |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 08/06/1993 |
Decision Date | 11/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|