Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K020528 |
Device Name |
INTRASTENT LD (LARGE DIAMETER) STENT |
Applicant |
SULZER INTRATHERAPEUTICS, INC. |
651 CAMPUS DR. |
ST. PAUL,
MN
55112 -3495
|
|
Applicant Contact |
GLEN D SMYTHE |
Correspondent |
SULZER INTRATHERAPEUTICS, INC. |
651 CAMPUS DR. |
ST. PAUL,
MN
55112 -3495
|
|
Correspondent Contact |
GLEN D SMYTHE |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 02/19/2002 |
Decision Date | 04/16/2002 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|