Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K896518 |
Device Name |
DOBBHOFF(R) ERCP CANNULA |
Applicant |
BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. |
P.O. BOX 1700 |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
PETER WAEGER |
Correspondent |
BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. |
P.O. BOX 1700 |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
PETER WAEGER |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/15/1989 |
Decision Date | 02/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|