Device Classification Name |
Accessories, Blood Circuit, Hemodialysis
|
510(k) Number |
K003712 |
Device Name |
MODIFICATION TO MALE TO MALE LUER ADAPTER |
Applicant |
MOLDED PRODUCTS INC. |
P.O. BOX 15 |
HARLAN,
IA
51537
|
|
Applicant Contact |
ELISE JOHNSTON |
Correspondent |
MOLDED PRODUCTS INC. |
P.O. BOX 15 |
HARLAN,
IA
51537
|
|
Correspondent Contact |
ELISE JOHNSTON |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 12/01/2000 |
Decision Date | 05/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|