Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K031676 |
Device Name |
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q |
Applicant |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E |
MCGAW PARK,
IL
60085 -6730
|
|
Applicant Contact |
DAVID E CURTIN |
Correspondent |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E |
MCGAW PARK,
IL
60085 -6730
|
|
Correspondent Contact |
DAVID E CURTIN |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 05/30/2003 |
Decision Date | 11/20/2003 |
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 |
Yes
|
Recalls |
CDRH Recalls
|
|
|