Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K940965 |
Device Name |
ELIMINATOR BALLOON DILATOR |
Applicant |
C.R. BARD, INC. |
200 AMES POND DR. |
TEWKSBURY,
MA
01876
|
|
Applicant Contact |
JOHN A DELUCIA |
Correspondent |
C.R. BARD, INC. |
200 AMES POND DR. |
TEWKSBURY,
MA
01876
|
|
Correspondent Contact |
JOHN A DELUCIA |
Regulation Number | 876.5010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/02/1994 |
Decision Date | 05/20/1994 |
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
|
|
|