Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K963933 |
Device Name |
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER |
Applicant |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
ANN MARIE PAHLMAN |
Correspondent |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
ANN MARIE PAHLMAN |
Regulation Number | 876.5820 |
Classification Product Code |
|
Date Received | 10/01/1996 |
Decision Date | 11/24/1997 |
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
|
|
|