Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K940370 |
Device Name |
AMERICAN CATHETER E.R.C.P. CANNULA |
Applicant |
INTL. MEDICAL, INC. |
10061 AMBERWOOD RD. |
FORT MYERS,
FL
33913
|
|
Applicant Contact |
PETER H WETTERMANN |
Correspondent |
INTL. MEDICAL, INC. |
10061 AMBERWOOD RD. |
FORT MYERS,
FL
33913
|
|
Correspondent Contact |
PETER H WETTERMANN |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 01/26/1994 |
Decision Date | 08/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|