Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K011184 |
Device Name |
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS |
Applicant |
INTRATHERAPEUTICS, INC. |
651 CAMPUS DR. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
AMY PETERSON |
Correspondent |
INTRATHERAPEUTICS, INC. |
651 CAMPUS DR. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
AMY PETERSON |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/18/2001 |
Decision Date | 08/13/2001 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|