Device Classification Name |
Bag, Urine Collection, Newborn
|
510(k) Number |
K943752 |
Device Name |
RIMECO MIDSTREAM URINE COLLECTOR |
Applicant |
RIMECO PRODUCTS, INC. |
7603-B9 FIRST PLACE DR. |
OAKWOOD VILLAGE,
OH
44146
|
|
Applicant Contact |
VALENTIN RIBIC |
Correspondent |
RIMECO PRODUCTS, INC. |
7603-B9 FIRST PLACE DR. |
OAKWOOD VILLAGE,
OH
44146
|
|
Correspondent Contact |
VALENTIN RIBIC |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 08/02/1994 |
Decision Date | 11/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|