Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K010549 |
Device Name |
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) |
Applicant |
MEDI-GLOBE CORP. |
6202 SOUTH MAPLE AVE. # 131 |
TEMPE,
AZ
85283
|
|
Applicant Contact |
SCOTT KARLER |
Correspondent |
MEDI-GLOBE CORP. |
6202 SOUTH MAPLE AVE. # 131 |
TEMPE,
AZ
85283
|
|
Correspondent Contact |
SCOTT KARLER |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 02/26/2001 |
Decision Date | 01/18/2002 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|