Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K863437 |
Device Name |
BARD BALLOON DILATATION SYSTEM |
Applicant |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Applicant Contact |
CATHERINE V BEATH |
Correspondent |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Correspondent Contact |
CATHERINE V BEATH |
Regulation Number | 876.5010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/05/1986 |
Decision Date | 10/29/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|