Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K892383 |
Device Name |
BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET |
Applicant |
PORGES CORP. |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Applicant Contact |
HARRY M KAUFMAN |
Correspondent |
PORGES CORP. |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Correspondent Contact |
HARRY M KAUFMAN |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/06/1989 |
Decision Date | 05/04/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|