Device Classification Name |
tubing, dialysate
|
510(k) Number |
K022068 |
Device Name |
TUBING, DIALYSATE (AND CONNECTOR) |
Applicant |
MOLDED PRODUCTS INC. |
601 DURANT ST. |
HARLAN,
IA
51537
|
|
Applicant Contact |
ELISE JOHNSTON |
Correspondent |
MOLDED PRODUCTS INC. |
601 DURANT ST. |
HARLAN,
IA
51537
|
|
Correspondent Contact |
ELISE JOHNSTON |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 06/25/2002 |
Decision Date | 09/23/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|