Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K032975 |
Device Name |
JMS BLOOD TUBING SETS |
Applicant |
JMS NORTH AMERICA CORP. |
22320 FOOTHILL BLVD., |
SUITE 350 |
HAYWARD,
CA
94541
|
|
Applicant Contact |
SWEE CHEAU |
Correspondent |
JMS NORTH AMERICA CORP. |
22320 FOOTHILL BLVD., |
SUITE 350 |
HAYWARD,
CA
94541
|
|
Correspondent Contact |
SWEE CHEAU |
Regulation Number | 876.5820 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/24/2003 |
Decision Date | 08/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|