Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K013737 |
Device Name |
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON |
Applicant |
TELEMED SYSTEMS, INC. |
8 KANE INDUSTRIAL DR. |
HUDSON,
MA
01749
|
|
Applicant Contact |
MICHAEL CARROLL |
Correspondent |
TELEMED SYSTEMS, INC. |
8 KANE INDUSTRIAL DR. |
HUDSON,
MA
01749
|
|
Correspondent Contact |
MICHAEL CARROLL |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/13/2001 |
Decision Date | 03/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|