Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K103353 |
Device Name |
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER |
Applicant |
NAVILYST MEDICAL, INC. |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
WANDA CARPINELLA |
Correspondent |
NAVILYST MEDICAL, INC. |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
WANDA CARPINELLA |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/16/2010 |
Decision Date | 01/14/2011 |
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
|
|
|