Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K152129 |
Device Name |
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution |
Applicant |
BAXTER HEALTHCARE CORPORATION |
32650 N. WILSON ROAD |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
TIFFANY LIN |
Correspondent |
BAXTER HEALTHCARE CORPORATION |
32650 N. WILSON ROAD |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
TIFFANY LIN |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 07/31/2015 |
Decision Date | 10/29/2015 |
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
|
Recalls |
CDRH Recalls
|
|
|