Device Classification Name |
Bag, Bile Collecting
|
510(k) Number |
K901844 |
Device Name |
URESIL TRU-CLOSE DRAINAGE BAG |
Applicant |
URESIL CORP. |
5418 W. TOUHY AVE. |
SKOKIE,
IL
60077
|
|
Applicant Contact |
LEV MELINYSHYN |
Correspondent |
URESIL CORP. |
5418 W. TOUHY AVE. |
SKOKIE,
IL
60077
|
|
Correspondent Contact |
LEV MELINYSHYN |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/24/1990 |
Decision Date | 06/01/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|