Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K972579 |
Device Name |
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE |
Applicant |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
DAVID C ROSS |
Correspondent |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
DAVID C ROSS |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 07/10/1997 |
Decision Date | 10/01/1997 |
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
|
|
|