Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K010714 |
Device Name |
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 |
Applicant |
MEDI-GLOBE CORP. |
MEDI-GLOB-STRASSE 1-5 |
ACHENMUHLE,
DE
|
|
Applicant Contact |
GERHARDT SEIWERTH |
Correspondent |
MEDI-GLOBE CORP. |
MEDI-GLOB-STRASSE 1-5 |
ACHENMUHLE,
DE
|
|
Correspondent Contact |
GERHARDT SEIWERTH |
Regulation Number | 876.5010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/09/2001 |
Decision Date | 01/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|