Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K111149 |
Device Name |
HANAROSTENT BILIARY (NNN) |
Applicant |
M.I. TECH CO., LTD. |
1733 CANTON LANE |
MARIETTA,
GA
30062
|
|
Applicant Contact |
PAUL SUMNER |
Correspondent |
M.I. TECH CO., LTD. |
1733 CANTON LANE |
MARIETTA,
GA
30062
|
|
Correspondent Contact |
PAUL SUMNER |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/25/2011 |
Decision Date | 12/30/2011 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|