Device Classification Name |
System, Perfusion, Kidney
|
510(k) Number |
K153384 |
Device Name |
Low Potassium Dextran Solution with Tris Diluent |
Applicant |
United Therapeutics Corporation |
55 TW Alexander Drive, PO Box 14186 |
Research Triangle Park,
NC
27709
|
|
Applicant Contact |
Rita Lee |
Correspondent |
United Therapeutics Corporation |
55 TW Alexander Drive, PO Box 14186 |
Research Triangle Park,
NC
27709
|
|
Correspondent Contact |
Rita Lee |
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 11/23/2015 |
Decision Date | 02/19/2016 |
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
|
|
|